FDA UDI
In Commercial Distribution
🇺🇸 United States
Soosung Non-Woven Fabric
DI: 08809968572947
·
Model: 5cmx5cmx4p
·
soosung medical
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
200
Basic Information
- Brand Name
- Soosung Non-Woven Fabric
- Primary DI
- 08809968572947
- Version / Model
- 5cmx5cmx4p
- Company Name
- soosung medical
- Labeler DUNS
- 694727366
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 200
- Record Status
- Published
- Publish Date
- 2025-12-10
- Public Version
- 1
- Public Version Date
- 2025-12-18
- Public Version Status
- New
- Public Device Record Key
- 965851d7-b472-40e9-a8fa-fb827f86c49b
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
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NAB | Gauze / Sponge,Nonresorbable For External Use | General, Plastic Surgery | 878.4014 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48131 | Non-woven gauze pad | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 08809968572930 | GS1 | ||||
| Primary | 08809968572947 | GS1 |
Customer Contacts
- Phone
- +821036973950
- [email protected]