FDA.reportPublic FDA data

Kroger

Primary DI
00041260383847
Brand
Kroger
Company
KROGER CO., THE
Model
041260383847
Device description
Large Gauze Pads, all one size, 4 IN x 4 IN
Published
2019-08-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

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
10041260383844PackageGS172Not in Commercial Distribution
00041260383847PrimaryGS10
60041260383849Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1004126038384410041260383844
00041260383847000412603838470412603838470041260383847
6004126038384960041260383849

GMDN Terms#

Term, Definition table
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.

Regulatory Flags#

DUNS number
006999528
Device count
10
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00041260025747Kroger04126002574763610912025-08-05
00041260011658Kroger PJ Masks0412600116582021-01-13
00041260017957Kroger0412600179572023-01-31
00041260017964Kroger0412600179642023-01-31
00041260377501Kroger0412603775012020-08-17
00041260377518Kroger0412603775182019-10-30
00041260383809Kroger0412603838092020-06-22
00041260383816Kroger0412603838162020-06-22
00041260026850Kroger0412600268502026-03-09
60041260026852Kroger0412600268502026-03-09
60041260025749Kroger04126002574763610912025-08-05
10041260346962Kroger Blood Glucose Test Strips8000-042412016-09-24
10041260346979Kroger Blood Glucose Test Strips8000-042412016-09-24
10041260360685Kroger Premium Blood Glucose Meter8000-067682016-09-24
10041260360692Kroger Premium Blood Glucose Test Strips8000-067622016-09-24
00011110338235Kroger Pen Needles7000013332016-09-24
00041260003592Kroger Pen Needles7000147202019-06-01
00041260003608Kroger Pen Needles7000147212019-06-01
00041260343469Kroger Pen Needles7000013322016-09-24
00041260364624Kroger Pen Needles7000013312016-09-24

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