Debridement Kit, Sterile

FDA UDI

Class I (US FDA UDI)

by Dynarex Corp.

Identity

Trade Name: Debridement Kit, Sterile FDA UDI
Generic Name: Burn kit, non-medicated FDA UDI
Device Name: Contents: 1 Cotton Tip Applicator, 1 Scalpel #11, 1 Iris Scissors, Straight, 2 Gauze Pads 4x4, 1 Adson Forceps, 1 Alcohol prep pad. STERILE-EO FDA UDI
Model / Reference: 4150 FDA UDI
Description: Contents: 1 Cotton Tip Applicator, 1 Scalpel #11, 1 Iris Scissors, Straight, 2 Gauze Pads 4x4, 1 Adson Forceps, 1 Alcohol prep pad. STERILE-EO FDA UDI

Identifiers

Primary DI / UDI-DI: 00840117338012 FDA UDI
FDA Product Code: KDD FDA UDI
GMDN Term: Burn kit, non-medicated FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Burn kit, non-medicated

Debridement Kit, Sterile by Dynarex Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: Dynarex Corp.

Sources (1)

FDA UDI 16e6d813-153d-4ea7-adbd-75117a774695 33 fields · synced Jun 6, 2026