Identity
- Trade Name
- Key Surgical Sterile Labels FDA UDI
- Generic Name
- Procedural medication labelling set FDA UDI
- Device Name
- Sterile Labels - Sterile Labels - Custom, 10 labels per panel, 2 panels per pouch, 100 pouches per Box FDA UDI
- Model / Reference
- SL-210 FDA UDI
- Description
- Sterile Labels - Sterile Labels - Custom, 10 labels per panel, 2 panels per pouch, 100 pouches per Box FDA UDI
Identifiers
- Catalog Number
- SL210 FDA UDI
- Primary DI / UDI-DI
- 00849771032144 FDA UDI
- FDA Product Code
- LYV FDA UDI
- GMDN Term
- Procedural medication labelling set FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
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
Key Surgical Sterile Labels by Key Surgical, LLC — 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 |
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Manufacturer
- Manufacturer
- Key Surgical, LLC
Sources (1)
- FDA UDI ac0f0b8d-9fc6-4045-9022-6076b7351bf5 36 fields · synced Jun 1, 2026