FDA.report

MEDLINE

Primary DI
20193489007807
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
FG56783
Catalog number
FG56783
Device description
GAUZE PRM NW 2X2 6PLY SLIT NS
Published
2025-06-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
20193489007807PackageGS125In Commercial Distribution
00193489007803PrimaryGS10
10193489007800Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2019348900780720193489007807
00193489007803001934890078031934890078030193489007803
1019348900780010193489007800

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.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
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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20080196286789MEDLINEMDT2168282MDT21682822016-10-14
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20884389155377MEDLINENONLV240XLNONLV240XL2025-05-27
20888277336893MEDLINENON50240NON502402025-05-27

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20665973020932DukalDukal LLCNAB2026-01-30
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00810194401831AiraAIRA, LLCNAB2026-01-16
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00723896029640Practicon® Premium 4x4 Non-Woven Sponges 200/PackPRACTICON, INC.NAB2026-01-07
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