Identity
- Trade Name
- Premium Multifire TA FDA UDI
- Generic Name
- Open-surgery manual linear stapler, single-use FDA UDI
- Device Name
- Vascular Stapler FDA UDI
- Model / Reference
- 010315 FDA UDI
- Description
- Vascular Stapler FDA UDI
Identifiers
- Catalog Number
- 010315 FDA UDI
- Primary DI / UDI-DI
- 10884521045965 FDA UDI
- 510(k) Number
- K801589 FDA UDI
- FDA Product Code
- FHM FDA UDI
- GMDN Term
- Open-surgery manual linear stapler, single-use 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 30 Millimeter FDA UDI
Premium Multifire TA by Covidien LP — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K801589 also covers:
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
- Covidien LP
Sources (1)
- FDA UDI 4f158036-0f17-4158-9b80-44c73125006e 39 fields · synced Jun 1, 2026