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Hcs

FDA UDI

Class I (US FDA UDI)

by Concordance Healthcare Solutions LLC

Identity

Trade Name
HCS FDA UDI
Generic Name
Woven gauze pad, non-antimicrobial FDA UDI
Device Name
Type VII Gauze, Non-Sterile, 4" x 4", 8-ply FDA UDI
Model / Reference
93448NS FDA UDI
Description
Type VII Gauze, Non-Sterile, 4" x 4", 8-ply FDA UDI

Identifiers

Primary DI / UDI-DI
00810132044120 FDA UDI
FDA Product Code
NAB FDA UDI
GMDN Term
Woven gauze pad, non-antimicrobial FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4014 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

No

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Woven gauze pad, non-antimicrobial

The HCS gauze, non-sterile and 4' x 4', 8-ply, type VII, is a single-use device designed for external use. It's primarily used to clean wounds or abrasions, absorb exudates, or apply topical medications.

Similar devices

Also classified as Woven gauze pad, non-antimicrobial.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Concordance Healthcare Solutions LLC

Sources (1)

  • FDA UDI 6914e224-80eb-4f53-a9bf-6bbd4ef3cf9c 33 fields · synced Oct 6, 2026