Device
Elyra Thulium Laser Fiber, 272 µm, Ball Tip, Single Use
Manufacturer
C. R. Bard, Inc.
Model: 7082327 Catalog: 7082327 DI: 00801741225697 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, 272 µm, Ball Tip, Single Use
Sterilization
Device Sterile: Yes
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: c9246bfb-61c0-499b-af1d-bcc0110717de
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
Item #1 - Pkg Type: Case
Item #1 - Device ID: 20801741225691
Item #1 - Pkg Status: In Commercial Distribution
Item #1 - Pkg Quantity: 10
Item #1 - Device ID Type: Package
Item #1 - Contains DINumber: 10801741225694
Item #1 - Device ID Issuing Agency: GS1
Item #2 - Pkg Type: Pack or Inner Pack
Item #2 - Device ID: 10801741225694
Item #2 - Pkg Status: In Commercial Distribution
Item #2 - Pkg Quantity: 5
Item #2 - Device ID Type: Package
Item #2 - Contains DINumber: 00801741225697
Item #2 - Device ID Issuing Agency: GS1
Item #3 - Device ID: 00801741225697
Item #3 - Device ID Type: Primary
Item #3 - Device ID 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 = 272 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