FDA.report

New Soosung Elastic Bandage

Primary DI
08809302580928
Brand
New Soosung Elastic Bandage
Company
soosung medical
Model
5cm x 215cm
Published
2025-12-26
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

Related Records

Product Codes

CodeName
FQMBandage, Elastic

Product Code Classifications

CodeDeviceSpecialtyClass
FQMBandage, ElasticGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08809302580928PackageGS112In Commercial Distribution
08809302580997PackageGS140In Commercial Distribution
08809302580911PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08809302580928088093025809288809302580928
08809302580997088093025809978809302580997
08809302580911088093025809118809302580911

GMDN Terms

TermDefinition
Pressure bandage, non-latex, single-useA strip or roll of fabric or plastic material (non-natural rubber latex) intended to be applied to and compress a local area of the body for one or more preventative/therapeutic applications (e.g., prevent oedema, support injuries associated with minor trauma, treat disorders of venous return). It may be described as a sports tape intended for support while allowing movement, or described as a compression bandage; it is not intended to be used in association with open wounds. It is intended for use in the home or healthcare facility. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
5419920770hay9101@gmail.com

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 DIBrandModelCatalogPublished
08809302580652New Soosung Elastic Bandage7.5cm x 215cm2025-12-26
08809302580683New Soosung Elastic Bandage10cm x 215cm2025-12-26
08809302580874New Soosung Elastic Bandage15cm x 215cm2025-12-24
08809302587538Soosung Elastic Bandage2"2025-12-11
08809302587545Soosung Elastic Bandage3"2025-12-11
08809302587552Soosung Elastic Bandage4"2025-12-11
08809302587569Soosung Elastic Bandage6"2025-12-11
08809968572930Soosung Non-Woven Fabric5cmx5cmx4p2025-12-10
08809968572954Soosung Non-Woven Fabric7.5cmx7.5cmx4p2025-12-10
08809968572978Soosung Non-Woven Fabric10cmx10cmx4p2025-12-10
08809968579922Soosung Sterile Gauze Pads10cm x 10cm x 8p2024-09-11
08809968579953Soosung Sterile Gauze Pads7.5cm x 7.5cm x 8p2024-09-11
08809968579984Soosung Sterile Gauze Pads5cm x 5cm x 8p 2024-09-11

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