FDA.reportPublic FDA data

Soosung Non-Woven Fabric

Primary DI
08809968572954
Brand
Soosung Non-Woven Fabric
Company
soosung medical
Model
7.5cmx7.5cmx4p
Device description
Fibres made with materials from natural, chemical, synthetic, etc. or mixtures using binders and machines, and has better absorption than gauze. For wounding and surgical treatment
Published
2025-12-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
08809968572961PrimaryGS10
08809968572954Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809968572961088099685729618809968572961
08809968572954088099685729548809968572954

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+821036973950hay9101@gmail.com

Regulatory Flags#

DUNS number
694727366
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
true
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
08809302586364Soosung Self-Adhesive BandagePB1 / 2.5cm*4.5m2026-06-08
08809302586395Soosung Self-Adhesive BandagePB2 / 5cm*4.5m2026-06-08
08809302586425Soosung Self-Adhesive BandagePB3 / 7.5cm*4.5m2026-06-08
08809302586487Soosung Self-Adhesive BandagePB4 / 10cm*4.5m2026-06-08
08809302580645New Soosung Elastic Bandage7.5cm x 215cm2025-12-26
08809302580676New Soosung Elastic Bandage10cm x 215cm2025-12-26
08809302580911New Soosung Elastic Bandage5cm x 215cm2025-12-26
08809302580652New Soosung Elastic Bandage7.5cm x 215cm2025-12-26
08809302580683New Soosung Elastic Bandage10cm x 215cm2025-12-26
08809302580928New Soosung Elastic Bandage5cm x 215cm2025-12-26
08809302580867New Soosung Elastic Bandage15cm x 215cm2025-12-24
08809302580874New Soosung Elastic Bandage15cm x 215cm2025-12-24
08809302587217Soosung Elastic Bandage"2"""2025-12-11
08809302587224Soosung Elastic Bandage"3"""2025-12-11
08809302587231Soosung Elastic Bandage"4"""2025-12-11
08809302587248Soosung Elastic Bandage"6"""2025-12-11
08809302587538Soosung Elastic Bandage2"2025-12-11
08809302587545Soosung Elastic Bandage3"2025-12-11
08809302587552Soosung Elastic Bandage4"2025-12-11
08809302587569Soosung Elastic Bandage6"2025-12-11

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Primary DI, Brand, Company table
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06975675784750RESCUE RESSENTIALSEMSRUN GROUPNAB2026-09-22
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06979032641168Thomas Jane MedicalHUZHOU JUNDA INDUSTRY CO., LTD.NAB2026-06-27
06979032641175Thomas Jane MedicalHUZHOU JUNDA INDUSTRY CO., LTD.NAB2026-06-27
00197344173993CURADMEDLINE INDUSTRIES, INC.NAB2026-06-24
00197344174006CURADMEDLINE INDUSTRIES, INC.NAB2026-06-24
00840456203330JMUJMU DENTAL, INCNAB2026-06-23
00840456203347JMUJMU DENTAL, INCNAB2026-06-23
00840456203354JMUJMU DENTAL, INCNAB2026-06-23
00840456224199JMUJMU DENTAL, INCNAB2026-06-23
00840456224205JMUJMU DENTAL, INCNAB2026-06-23
06924105625026BOENMEDBOEN HEALTHCARE CO., LTD.NAB2026-06-03
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