FDA.report

Medline

Primary DI
20080196690647
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
NON21422
Catalog number
NON21422
Device description
GAUZE,SPONGE,3"X3",12PLY,STERILE,LF,2'S
Published
2021-02-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
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
20080196618306PackageGS12In Commercial Distribution
20080196690647PackageGS12In Commercial Distribution
30080196618303PackageGS140In Commercial Distribution
30080196690644PackageGS140In Commercial Distribution
40080196618300PackageGS130In Commercial Distribution
40080196690641PackageGS12400In Commercial Distribution
10080196618309PrimaryGS10
10080196690640Unit of UseGS10

Alternate GTIN/UPC/EAN values are derived from GS1 digit structure for lookup convenience. Do not treat derived UPC-A or EAN-13 values as separate FDA identifiers. GTIN-14 values with indicator digits 1-9 usually represent packaging levels, cases, pallets, or variable-measure items and are not converted to UPC-A/EAN-13 here.

Alternate GTIN / UPC / EAN Codes

Source identifierSource lengthGTIN-14 normalizedIndicatorConversion note
2008019661830614200801966183062Indicator 2 usually represents packaging or variable measure; UPC/EAN conversion is not shown.
2008019669064714200801966906472Indicator 2 usually represents packaging or variable measure; UPC/EAN conversion is not shown.
3008019661830314300801966183033Indicator 3 usually represents packaging or variable measure; UPC/EAN conversion is not shown.
3008019669064414300801966906443Indicator 3 usually represents packaging or variable measure; UPC/EAN conversion is not shown.
4008019661830014400801966183004Indicator 4 usually represents packaging or variable measure; UPC/EAN conversion is not shown.
4008019669064114400801966906414Indicator 4 usually represents packaging or variable measure; UPC/EAN conversion is not shown.
1008019661830914100801966183091Indicator 1 usually represents packaging or variable measure; UPC/EAN conversion is not shown.
1008019669064014100801966906401Indicator 1 usually represents packaging or variable measure; UPC/EAN conversion is not shown.

GMDN Terms

TermDefinition
Woven gauze pad, sterileA non-medicated 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: clean, cover, or pack wounds or abrasions and absorb their exudates; absorb body-surface exudates; or apply topical medications. This is a single-use device.

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
025460908
Device count
2
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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40888277170972MEDLINEFG1503FG15032026-03-20
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40888277358462MEDLINEMPHPN318MPHPN3182026-03-19
20197344009807HUDSON RCIHUD2417HUD24172026-03-19
20080196286789MEDLINEMDT2168282MDT21682822016-10-14
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20884389108199MEDLINE INDUSTRIES, INC.NONLV200XXXLNONLV200XXXL2024-03-05
20884389108229MEDLINENONLV200XXLNONLV200XXL2025-05-27
20884389155360MEDLINENONLV240NONLV2402025-05-27
20884389155377MEDLINENONLV240XLNONLV240XL2025-05-27
20888277336893MEDLINENON50240NON502402025-05-27

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