Identity
- Trade Name
- 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 packages per box FDA UDI
- Model / Reference
- SL201 FDA UDI
- Description
- Sterile Labels - Sterile Labels - Custom, 10 labels per panel, 2 panels per pouch, 100 packages per box FDA UDI
Identifiers
- Catalog Number
- SL201 FDA UDI
- Primary DI / UDI-DI
- 10849771052842 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
- 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
Category: Procedural medication labelling set
Sterile Labels by Key Surgical, LLC — Class I — 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 | Class I | Pending data |
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Manufacturer
- Manufacturer
- Key Surgical, LLC
Sources (1)
- FDA UDI 3a70ca96-f5d4-4233-99e5-905ea2d05a8c 35 fields · synced May 30, 2026