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Coe-Pak™

FDA UDI

Class II (US FDA UDI)

by Gc America Inc.

Identity

Trade Name
COE-PAK™ FDA UDI
Generic Name
Clinical periodontal dressing FDA UDI
Device Name
COE-PAK™ Automix NDS (2 x 50mL cartridges & 12 mixing tips) FDA UDI
Model / Reference
135003 FDA UDI
Description
COE-PAK™ Automix NDS (2 x 50mL cartridges & 12 mixing tips) FDA UDI

Identifiers

Catalog Number
135003 FDA UDI
Primary DI / UDI-DI
10386040000321 FDA UDI
510(k) Number
K881422 FDA UDI
FDA Product Code
EMA FDA UDI
GMDN Term
Clinical periodontal dressing FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3275 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Clinical periodontal dressing

Coe-Pak™ by Gc America Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Clinical periodontal dressing.

Cleared under the same submission

K881422 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gc America Inc.

Sources (1)

  • FDA UDI b3394f30-f02e-4004-b84a-f81f427aae0f 37 fields · synced Jun 6, 2026