FDA UDI
In Commercial Distribution
🇺🇸 United States
A Plus
DI: 00683534850046
·
Model: 1
·
A PLUS INTERNATIONAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- A Plus
- Primary DI
- 00683534850046
- Version / Model
- 1
- Catalog Number
- SAB0875-1
- Company Name
- A PLUS INTERNATIONAL INC.
- Labeler DUNS
- 191705904
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-19
- Public Version
- 1
- Public Version Date
- 2022-10-27
- Public Version Status
- New
- Public Device Record Key
- cd98db8e-715f-4500-beb5-8a062b16d536
Device Description
Absorb Plus Gauze Sponges(None-Woven): 1's Pack Sterile ABD Pad , 8"X7.5", 1Pc(s)/Pack, 240 Packs/Case
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EFQ | Gauze/Sponge, Internal | Unknown | U |
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. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 70683534850045 | GS1 | Inner Pack | 1 | In Commercial Distribution | |
| Primary | 00683534850046 | GS1 | ||||
| Package | 80683534850042 | GS1 | Case | 240 | In Commercial Distribution |