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Premium Plus CEEA

FDA UDI

Class II (US FDA UDI)

by Covidien LP

Identity

Trade Name
Premium Plus CEEA FDA UDI
Generic Name
Intraluminal circular stapler, single-use FDA UDI
Device Name
Circular Stapler FDA UDI
Model / Reference
111985 FDA UDI
Description
Circular Stapler FDA UDI

Identifiers

Primary DI / UDI-DI
10884523006599 FDA UDI
510(k) Number
K001895 FDA UDI
FDA Product Code
GDW FDA UDI
GMDN Term
Intraluminal circular stapler, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4750 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

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
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 25 Millimeter FDA UDI

Category: Intraluminal circular stapler, single-use

Premium Plus CEEA by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intraluminal circular stapler, single-use.

Cleared under the same submission

K001895 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Covidien LP

Sources (1)

  • FDA UDI a7207c55-e2eb-45cf-a207-3716a79f6bd5 37 fields · synced May 30, 2026