Identity
- Trade Name
- 272 ScopeSafe Laser Fiber with Soft Tip FDA UDI
- Generic Name
- General/multiple surgical laser system beam guide, single-use FDA UDI
- Device Name
- 272 ScopeSafe Laser Fiber with Soft Tip FDA UDI
- Model / Reference
- OI-0272S-FT-ST0-LEX-1 FDA UDI
- Description
- 272 ScopeSafe Laser Fiber with Soft Tip FDA UDI
Identifiers
- Catalog Number
- 11521 FDA UDI
- Primary DI / UDI-DI
- 00810077630495 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- General/multiple surgical laser system beam guide, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 272 Micrometer FDA UDI
Category: General/multiple surgical laser system beam guide, single-use
272 ScopeSafe Laser Fiber with Soft Tip by Optical Integrity, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as General/multiple surgical laser system beam guide, single-use.
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- Olympus — Gyrus Acmi, Inc. · Class II
- Dornier MedTech — Dornier MedTech America, Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Optical Integrity, Inc.
Sources (1)
- FDA UDI 857e6492-f757-4483-806d-c752416afd30 37 fields · synced Jun 8, 2026