Eea

FDA UDI

Class II (US FDA UDI)

by Covidien LP

Identity

Trade Name: EEA FDA UDI
Generic Name: Intraluminal circular stapler, single-use FDA UDI
Device Name: Circular Stapler with DST Series Technology FDA UDI
Model / Reference: EEAXL21 FDA UDI
Description: Circular Stapler with DST Series Technology FDA UDI

Identifiers

Primary DI / UDI-DI: 10884523005578 FDA UDI
510(k) Number: K062850 FDA UDI
K221003 FDA UDI
FDA Product Code: GDW FDA UDI
GAG FDA UDI
GMDN Term: Intraluminal circular stapler, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4750 FDA UDI
878.4740 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Height — 4.8 Millimeter FDA UDI
Outer Diameter — 21 Millimeter FDA UDI

Category: Intraluminal circular stapler, single-use

Eea 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.

Circular Stapler — B. J. ZH. F. Panther Medical Equipment Co., Ltd. · Class II
Single Use Circular Stapler — Golden Stapler Surgical Co., Ltd · Class II
Single Use Circular Stapler — Golden Stapler Surgical Co., Ltd · Class II
Single Use Circular Stapler — Golden Stapler Surgical Co., Ltd · Class II
Single Use Circular Stapler — Golden Stapler Surgical Co., Ltd · Class II
Single Use Circular Stapler — Golden Stapler Surgical Co., Ltd · Class II
Circular Stapler — B. J. ZH. F. Panther Medical Equipment Co., Ltd. · Class II
Circular Stapler — B. J. ZH. F. Panther Medical Equipment Co., Ltd. · Class II

Cleared under the same submission

K062850 also covers:

K221003 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 II	Pending data

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Manufacturer

Manufacturer: Covidien LP

Sources (1)

FDA UDI 593163ff-26a6-4cdf-8ffe-8b0773df1b49 37 fields · synced Jun 8, 2026