Device
Elyra Thulium Laser Fiber, 150 µm, Standard Tip, Single Use
Manufacturer
C. R. Bard, Inc.
C. R. Bard, Inc.
Model: 7082115
Catalog: 7082115
DI: 00801741225253
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-05
Current Version: 2026-05-13
Description
Elyra Thulium Laser Fiber, 150 µm, Standard Tip, Single Use
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
60a6312a-67aa-4ec7-9d1a-55149550be9a
Distribution Status:
In Commercial Distribution
DUNS Number:
016898496
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00801741225253
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 Text:
Diameter = 150 micrometre (µm)
Device Size - Size Type:
Device Size Text, specify
Environmental Conditions
Item #1 - Storage Handling Type:
Special Storage Condition, Specify
Item #1 - Storage Handling Special Condition Text:
Keep away from sunlight
Item #2 - Storage Handling Type:
Special Storage Condition, Specify
Item #2 - Storage Handling Special Condition Text:
Keep dry
Item #3 - Storage Handling Type:
Special Storage Condition, Specify
Item #3 - Storage Handling Special Condition Text:
Fragile, handle with care