FDA.reportPublic FDA data

Medi-First Sterile Gauze Pads 2 x 2 (25 count)

Primary DI
50347682620733
Brand
Medi-First Sterile Gauze Pads 2 x 2 (25 count)
Company
Medique Products
Model
62073
Catalog number
62073
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
NABGauze / Sponge,Nonresorbable For External Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50347682620733PackageGS112In Commercial Distribution
00347682620738PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5034768262073350347682620733
00347682620738003476826207383476826207380347682620738

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00347682713010Medi-First Large Instant Hot Pack71301713012019-07-12
00347682607012"Medi-First Waterproof Latex Free First Aid Tape 1/2"", 5 yds"60701607012019-07-03
00347682641016Medi-Stopper6401641012019-07-12
00347682696016"Medi-First Gauze Compress 24"" x 72"""69601696012019-07-19
00347682898014Medi-First Combine ABD Pad89801898012019-07-12
00347682642129Medi-First Non-Adherent Sterile Pads (10 count)64212642122019-07-12
00347682810016Medi-First Emergency Survival Blanket81001810012019-07-12
00347682623012"Medi-First Elastic Tape 1"" x 5 yards"62301623012019-07-24
00347682656997Medi-First 1/2 x 2 5 yards65699656992019-07-19
00347682660024Medi-First Tourniquet66002660022019-07-12
00347682656225Medi-First Adhesive Tape 1/2 x 2 5 yards656B656B2019-07-19
00347682135126Medi-First Plus Sterile Gauze Pads 2 x 2 (10 count)1035121035122019-07-12
00347682135737Medi-First Plus Sterile Gauze Pads 3 x 3 (25 count)1035731035732019-07-12
00347682136123Medi-First Plus Sterile Gauze Pads 3 x 3 (10 count)1036121036122019-07-12
00347682136734Medi-First Plus Sterile Gauze Pads 4 x 4 (25 count)1036731036732019-07-12
00347682137120Medi-First Plus Sterile Gauze Pads 4 x 4 (10 count)1037121037122019-07-12
00347682137731Medi-First Plus Sterile Gauze Pads 2 x 2 (25 count)1037731037732019-07-12
00347682606121Medi-First Sterile Gauze Pads 2 x 2 (10 count)60612606122019-07-12
00347682606336Medi-First Sterile Gauze Pads 3 x 3 (100 count)60633606332019-07-12
00347682606732Medi-First Sterile Gauze Pads 3 x 3 (25 count)60673606732019-07-12

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