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Kentex

FDA UDI

Class I (US FDA UDI)

by Kentron Health Care, Inc.

Identity

Trade Name
KENTEX FDA UDI
Generic Name
General-purpose medical foam padding, single-use FDA UDI
Device Name
CARDBOARD SPLINT 12" WITH FULL FOAM FDA UDI
Model / Reference
826028 FDA UDI
Description
CARDBOARD SPLINT 12" WITH FULL FOAM FDA UDI

Identifiers

Primary DI / UDI-DI
00810003753779 FDA UDI
FDA Product Code
NOC FDA UDI
GMDN Term
General-purpose medical foam padding, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.3910 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: General-purpose medical foam padding, single-use

Kentex by Kentron Health Care, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General-purpose medical foam padding, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Kentron Health Care, Inc.

Sources (1)

  • FDA UDI 20b3fbd0-f0eb-4d00-8819-59b5366a446c 33 fields · synced May 30, 2026