Identity
- Trade Name
- Sklar Instruments FDA UDI
- Generic Name
- Urethral bougie, reusable FDA UDI
- Device Name
- OTIS BOUGIE A BOULE 8FR FDA UDI
- Model / Reference
- 85-1608 FDA UDI
- Description
- OTIS BOUGIE A BOULE 8FR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10649111065095 FDA UDI
- GMDN Term
- Urethral bougie, reusable FDA UDI
Classification
- 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Urethral bougie, reusable
Sklar Instruments by Sklar Corporation — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Sklar Corporation
Sources (1)
- FDA UDI f083cef0-9df3-444f-ac38-d210b3fb3fc4 33 fields · synced May 30, 2026