Identity
- Trade Name
- REMEL FDA UDI
- Generic Name
- Neutral buffered formalin IVD FDA UDI
- Device Name
- Formalin 10% (15ml) PK/288 FDA UDI
- Model / Reference
- R21641 FDA UDI
- Description
- Formalin 10% (15ml) PK/288 FDA UDI
Identifiers
- Catalog Number
- R21641 FDA UDI
- Primary DI / UDI-DI
- 00848838024054 FDA UDI
- FDA Product Code
- IFP FDA UDI
- GMDN Term
- Neutral buffered formalin IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4010 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Remel by Remel, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Remel, Inc.
Sources (1)
- FDA UDI 0d6a2c9e-399d-416f-a01f-e092122b2350 35 fields · synced Jun 1, 2026