Identity
- Trade Name
- TA 90 BN FDA UDI
- Generic Name
- Open-surgery manual linear stapler, reusable FDA UDI
- Device Name
- Reusable Notched Bariatric Stapler FDA UDI
- Model / Reference
- 010885 FDA UDI
- Description
- Reusable Notched Bariatric Stapler FDA UDI
Identifiers
- Catalog Number
- 010885 FDA UDI
- Primary DI / UDI-DI
- 10884521049024 FDA UDI
- 510(k) Number
- K801589 FDA UDI
- FDA Product Code
- FHM FDA UDI
- GMDN Term
- Open-surgery manual linear stapler, reusable 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
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 90 Millimeter FDA UDI
Ta 90 Bn 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 3ce60f54-2f5b-4c04-8122-b6897d132b77 38 fields · synced Jun 1, 2026