← Back to catalogue

TA Premium

FDA UDI

Class I (US FDA UDI)

by Covidien LP

Identity

Trade Name
TA Premium FDA UDI
Generic Name
Open-surgery manual linear stapler, reusable FDA UDI
Device Name
Reusable Stapler FDA UDI
Model / Reference
010450 FDA UDI
Description
Reusable Stapler FDA UDI

Identifiers

Primary DI / UDI-DI
10884521048980 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
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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Length — 30 Millimeter FDA UDI

Category: Open-surgery manual linear stapler, reusable

TA Premium by Covidien LP — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Open-surgery manual linear stapler, reusable.

Cleared under the same submission

K801589 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Covidien LP

Sources (1)

  • FDA UDI 1fc866b0-4745-4a39-83f1-64e626b6f59c 37 fields · synced May 30, 2026