FDA.report

Dermacea

Primary DI
30192253049385
Brand
Dermacea
Company
Cardinal Health 200, LLC
Model
442213
Catalog number
442213
Device description
Dermacea USP Type VII Gauze
Published
2024-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
NABGauze / sponge,nonresorbable for external use

Product Code Classifications

CodeDeviceSpecialtyClass
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30192253049385PackageGS125In Commercial Distribution
50192253049389PackageGS124In Commercial Distribution
20192253049388PrimaryGS10
10192253049381Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3019225304938530192253049385
5019225304938950192253049389
2019225304938820192253049388
1019225304938110192253049381

GMDN Terms

TermDefinition
Non-woven gauze padA non-medicated device in the form of a patch or swab (also referred to as a sponge) made from non-woven material (e.g., rayon/polyester) and primarily designed to absorb fluids for medical purposes. It is typically used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates, or to apply topical medications; it is intended to produce less lint and be less adherent than basic woven gauze pads; it does not include petrolatum; in some cases, the device’s packaging may be used as a disposable tray. This is a single-use device.

Device Sizes

TypeValueUnit
Length4Inch
Width4Inch

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
2
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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