Model: 7082001
Catalog: 7082001
DI: 00801741225239
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-06
Current Version: 2026-05-14
Description
Elyra Thulium Fiber Laser System
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
247f632c-6f64-4284-ba82-01c993f55c7d
Distribution Status:
In Commercial Distribution
DUNS Number:
016898496
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
Yes
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00801741225239
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 36170
Name: General/multiple surgical solid-state laser system
Definition:
A mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam intended for general surgery and/or multiple specialized surgical applications (non-dedicated), which may include treatment of vascular diseases. It vaporizes/ablates soft tissue with moderate haemostasis, little charring, and a thin zone of necrosis. It includes a light source, delivery/positioning device(s), and controls/foot-switch and emits a midinfrared wavelength. It does not include frequency doubling technology.
FDA Product Codes
GEX
Powered laser surgical instrument
Device Sizes
Device Size - Size - @attributes - Unit:
Kilogram
Device Size - Size - @attributes - Value:
82
Device Size - Size Type:
Weight
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling Low - @attributes - Value:
-20
Item #1 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling High - @attributes - Value:
50
Item #1 - Storage Handling Type:
Storage Environment Temperature
Item #2 - Storage Handling Low - @attributes - Unit:
KiloPascal
Item #2 - Storage Handling Low - @attributes - Value:
80
Item #2 - Storage Handling High - @attributes - Unit:
KiloPascal
Item #2 - Storage Handling High - @attributes - Value:
106
Item #2 - Storage Handling Type:
Storage Environment Atmospheric Pressure
Item #3 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #3 - Storage Handling Low - @attributes - Value:
20
Item #3 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #3 - Storage Handling High - @attributes - Value:
75
Item #3 - Storage Handling Type:
Storage Environment Humidity
Item #4 - Storage Handling Type:
Special Storage Condition, Specify
Item #4 - Storage Handling Special Condition Text:
Stacking limit by number
Item #5 - Storage Handling Type:
Special Storage Condition, Specify
Item #5 - Storage Handling Special Condition Text:
Keep dry
Item #6 - Storage Handling Type:
Special Storage Condition, Specify
Item #6 - Storage Handling Special Condition Text:
Fragile, handle with care
Item #7 - Storage Handling Type:
Special Storage Condition, Specify
Item #7 - Storage Handling Special Condition Text:
This way up