FDA UDI
In Commercial Distribution
🇺🇸 United States
BGEcare Sterile Gauze Sponge
DI: 06972403301043
·
Model: GS01040408025012S-1
·
Xuchang Zhende Surgical Dressing Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- BGEcare Sterile Gauze Sponge
- Primary DI
- 06972403301043
- Version / Model
- GS01040408025012S-1
- Company Name
- Xuchang Zhende Surgical Dressing Co., Ltd.
- Labeler DUNS
- 528104096
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-11
- Public Version
- 2
- Public Version Date
- 2021-08-24
- Public Version Status
- Update
- Public Device Record Key
- 62ca74ef-4ad2-4a2f-8ca8-4f1e088fcf82
Device Description
BGEcare Sterile Gauze Sponge 4''X4'', 8-Ply, 2 pieces/pack, 50 packs/box, 12 boxes/carton box
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
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 |
|---|---|---|---|---|
| 48134 | Woven gauze pad | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 06972403301050 | GS1 | box | 50 | In Commercial Distribution | |
| Primary | 06972403301043 | GS1 | ||||
| Package | 06972403301067 | GS1 | carton box | 12 | In Commercial Distribution |