Identity
- Trade Name
- Sklar® FDA UDI
- Generic Name
- Gas/fluid regulator gasket FDA UDI
- Device Name
- BUNT FCP HOLDER FDA UDI
- Model / Reference
- 10-1770 FDA UDI
- Description
- BUNT FCP HOLDER FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10649111379345 FDA UDI
- FDA Product Code
- FSM FDA UDI
- GMDN Term
- Gas/fluid regulator gasket FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Gas/fluid regulator gasket
Sklar® by Sklar Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gas/fluid regulator gasket.
- Organ Care System — TransMedics, Inc · Class III
- BF — Allied Medical LLC
- Marina Medical — MARINA MEDICAL INSTRUMENTS, INC. · Class I
- FENTEX — FENTEX medical GmbH · Class I
- Sklar® — Sklar Corporation · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sklar Corporation
Sources (1)
- FDA UDI 0fa26014-6de8-4269-b131-d349f0f9ec6e 33 fields · synced May 30, 2026