FDA.reportPublic FDA data

Soosung Sterile Gauze Pads

Primary DI
08809968579953
Brand
Soosung Sterile Gauze Pads
Company
soosung medical
Model
7.5cm x 7.5cm x 8p
Published
2024-09-11
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

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
08809968579953PackageGS120In Commercial Distribution
08809968579960PackageGS150In Commercial Distribution
08809968579946PrimaryGS10
08809968579892Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809968579953088099685799538809968579953
08809968579960088099685799608809968579960
08809968579946088099685799468809968579946
08809968579892088099685798928809968579892

GMDN Terms#

Term, Definition table
TermDefinition
Woven gauze padA non-medicated 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 table
Method

Contacts#

Phone, Email table
PhoneEmail
5419920770hay9101@gmail.com

Regulatory Flags#

DUNS number
694727366
Device count
5
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
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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00840456224199JMUJMU DENTAL, INCNAB2026-06-23
00840456224205JMUJMU DENTAL, INCNAB2026-06-23
06924105625026BOENMEDBOEN HEALTHCARE CO., LTD.NAB2026-06-03
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