Identity
- Trade Name
- Custom Medical Specialties, Inc. FDA UDI
- Generic Name
- Sterility label/tag FDA UDI
- Device Name
- Label Pack - Sterile FDA UDI
- Model / Reference
- CMS-5896 FDA UDI
- Description
- Label Pack - Sterile FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815849021853 FDA UDI
- FDA Product Code
- LYV FDA UDI
- GMDN Term
- Sterility label/tag 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
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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Sterility label/tag
Custom Medical Specialties, Inc. by Custom Assemblies, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sterility label/tag.
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C. · Class II
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C. · Class II
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C. · Class II
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C. · Class II
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C. · Class II
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C. · Class II
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C. · 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Custom Assemblies, Inc.
Sources (1)
- FDA UDI 4283d36c-98eb-460f-832a-c9cbb0afca0d 33 fields · synced May 30, 2026