FDA.report

Medi-First Sterile Gauze Pads 2x 2 (10 count)

Primary DI
50347682620122
Brand
Medi-First Sterile Gauze Pads 2x 2 (10 count)
Company
Medique Products
Model
62012
Catalog number
62012
Device description
A sterile wound cover, gauze pad, intended to be used as an initial, short-term treatment after an injury. The device is typically used to protect wounds, arrest bleeding, and introduce medications placed on the pad.
Published
2019-07-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

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
50347682620122PackageGS124In Commercial Distribution
00347682620127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
5034768262012250347682620122
00347682620127003476826201273476826201270347682620127

GMDN Terms

TermDefinition
First aid gauze/bandageA sterile wound cover intended to be used as an initial, short-term treatment after injury. It typically consists of a gauze pad (e.g., cotton wool or lint) that is attached to a roll bandage (e.g., cotton or cotton/viscose). The pad is applied directly to the wound, and the bandage is subsequently wrapped around the pad and secured. The device is typically used to protect wounds, arrest bleeding, and introduce medications placed on the pad. It is available [non-prescription] over-the-counter (OTC) for use in the home or clinical settings. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-634-7680cs@mediqueproducts.com

Regulatory Flags

DUNS number
086911794
Device count
1
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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