FDA.reportPublic FDA data

Soosung Self-Adhesive Bandage

Primary DI
08809302586425
Brand
Soosung Self-Adhesive Bandage
Company
soosung medical
Model
PB3 / 7.5cm*4.5m
Device description
Non-sterile, latex-free self-adherent elastic bandage intended to provide compression, support, and secure dressing retention. The bandage adheres to itself without the need for clips, pins, or adhesive tape and is intended for external use only.
Published
2026-06-08
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
KGXTape And Bandage, Adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809302586432PackageGS112In Commercial Distribution
08809302586449PackageGS116In Commercial Distribution
08809302586425PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809302586432088093025864328809302586432
08809302586449088093025864498809302586449
08809302586425088093025864258809302586425

GMDN Terms#

Term, Definition table
TermDefinition
Non-adhesive device retention bandageA piece or roll of material intended to be wrapped around a part of the body to secure a device (e.g., skin dressing, catheter, cannula) to the patient, without adhering to or compressing the body. It may be made from a variety or combination of materials, including cotton, viscose, and plastic (e.g., polyamide), and some types are cohesive (i.e., the bandage adheres to itself but not to other surfaces); it is used in various clinical specialties (e.g., dermatology, general/plastic surgery). This is a single-use device.

Regulatory Flags#

DUNS number
694727366
Device count
1
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
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
08809968572947Soosung Non-Woven Fabric5cmx5cmx4p2025-12-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809302586364Soosung Self-Adhesive Bandagesoosung medicalKGX2026-06-08
08809302586395Soosung Self-Adhesive Bandagesoosung medicalKGX2026-06-08
08809302586487Soosung Self-Adhesive Bandagesoosung medicalKGX2026-06-08
00814247021304Panniculus Retraction KitCLINICAL INNOVATIONS, LLCKGX2026-05-31
00814247021311Panniculus Retraction Kit: traxi and ABBy - SmallCLINICAL INNOVATIONS, LLCKGX2026-05-31
00814247021328Panniculus Retraction Kit: traxi and ABBy - LargeCLINICAL INNOVATIONS, LLCKGX2026-05-31
00850087488389CeeportCEEPORT INC.KGX2026-05-29
00850087488426CeeportCEEPORT INC.KGX2026-05-29
00050428142516CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-05-28
09420012436047Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDKGX2026-04-14
09420012436061Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDKGX2026-04-14
00819143026446HealquHealqu LLCKGX2026-03-05
10192253049817TelfaCardinal Health 200, LLCKGX2026-02-25
10192253050080TelfaCardinal Health 200, LLCKGX2026-02-25
10080196669523MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10080196669530MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10080196669547MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10618125192318AquaGuardTIDI PRODUCTS, LLCKGX2025-09-23
10198459392078MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGX2025-07-07
10080196691708CURADMEDLINE INDUSTRIES, INC.KGX2025-05-23
10198459343506MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGX2025-05-22
10192253050172TelfaCardinal Health 200, LLCKGX2025-04-18
10192253050189TelfaCardinal Health 200, LLCKGX2025-04-18
10385081120333Omnipod PodPalsInsulet CorporationKGX2025-04-16
10653160999003Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.KGX2025-04-07
10197106767726CARDINAL HEALTHCardinal Health 200, LLCKGX2024-10-31
10080196669417MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-07-31
10080196669493MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-07-31
10080196743032MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-07-31
09355751001259Seer HomeSEER MEDICAL HOLDINGS LIMITEDKGX2024-06-27