FDA.report

MediChoice

Primary DI
30885632070321
Brand
MediChoice
Company
OWENS & MINOR DISTRIBUTION, INC.
Model
GZ2502
Device description
Gauze Sponge Bulk Non-Sterile 2 Inch X 2 Inch 12-Ply 100% Cotton Single Use Only Not Made With Natural Rubber Latex MediChoice Non-Acute Only
Published
2020-09-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
30885632070321PackageGS140In Commercial Distribution
20885632070324PrimaryGS10
10885632070327Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3088563207032130885632070321
2088563207032420885632070324
1088563207032710885632070327

GMDN Terms

TermDefinition
Woven gauze pad, non-sterileA non-medicated, non-sterile device in the form of a patch or swab (also referred to as a sponge) made from woven material (e.g., cotton, cellulose) and primarily designed to absorb fluids for medical purposes; it does not include petrolatum. It is typically used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates, or to apply topical medications. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
007941230
Device count
200
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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