Identity
- Trade Name
- Halyard FDA UDI
- Generic Name
- General surgical procedure kit, medicated FDA UDI
- Model / Reference
- SETA007-03_0004 FDA UDI
Identifiers
- Catalog Number
- SETA007-03 FDA UDI
- Primary DI / UDI-DI
- 10809160325629 FDA UDI
- FDA Product Code
- LRO FDA UDI
- GMDN Term
- General surgical procedure kit, medicated FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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: General surgical procedure kit, medicated
Halyard by Avid Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Medline Industries, Inc. — MEDLINE INDUSTRIES, INC. · Class I
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Avid Medical, Inc.
Sources (1)
- FDA UDI 439af54d-b87e-4bc6-902e-d18477421682 34 fields · synced Jun 8, 2026