Identity
- Trade Name
- FlexGuard Fiber with Sheath FDA UDI
- Generic Name
- General/multiple surgical laser system beam guide, reusable FDA UDI
- Device Name
- 272 micrometer FlexGuard Fiber with Sheath FDA UDI
- Model / Reference
- 27750272U1FS FDA UDI
- Description
- 272 micrometer FlexGuard Fiber with Sheath FDA UDI
Identifiers
- Primary DI / UDI-DI
- B14527750272U1FS0 FDA UDI
- 510(k) Number
- K100194 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- General/multiple surgical laser system beam guide, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 272 Micrometer FDA UDI
FlexGuard Fiber with Sheath by Optical Integrity, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K100194 also covers:
- Flex-G Fiber with Sheath — OPTICAL INTEGRITY, INC.
- Flex-G Fiber with Sheath — OPTICAL INTEGRITY, INC.
- Flex-G Fiber with Sheath — OPTICAL INTEGRITY, INC.
- Flex-G Fiber with Sheath Calculase compatible — OPTICAL INTEGRITY, INC.
- Flex-G Fiber with Sheath Calculase compatible — OPTICAL INTEGRITY, INC.
- Flex-G Fiber with Sheath Calculase compatible — OPTICAL INTEGRITY, INC.
- Flex-G Laser Fiber with Extended Length Sheath — OPTICAL INTEGRITY, INC.
- Flex-G Laser Fiber with Extended Length Sheath — OPTICAL INTEGRITY, INC.
- Flex-G Laser Fiber with Extended Length Sheath — OPTICAL INTEGRITY, INC.
- LaserGuard™ Sheath — OPTICAL INTEGRITY, INC.
- ScopeGuardian™ Sheath only — OPTICAL INTEGRITY, INC.
- ScopeSafe™Laser Fiber — OPTICAL INTEGRITY, INC.
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 084af180-9188-4520-8b86-6b58e4af9d07 38 fields · synced May 30, 2026