← Back to catalogue

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 WITH THREE PIECE FOAM FDA UDI
Model / Reference
826027 FDA UDI
Description
CARDBOARD SPLINT WITH THREE PIECE FOAM FDA UDI

Identifiers

Primary DI / UDI-DI
00810003753755 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

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

Manufacturer

Manufacturer
Kentron Health Care, Inc.

Sources (1)

  • FDA UDI 929a9855-fdb1-4e1b-ba26-3927b0c22607 33 fields · synced Jun 8, 2026