FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Kroger
DI: 00011110351227
·
Model: 011110351227
·
KROGER CO., THE
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
Basic Information
- Brand Name
- Kroger
- Primary DI
- 00011110351227
- Version / Model
- 011110351227
- Company Name
- KROGER CO., THE
- Labeler DUNS
- 006999528
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2019-08-30
- Public Version
- 3
- Public Version Date
- 2021-08-24
- Public Version Status
- Update
- Public Device Record Key
- 10bdfa6d-7308-49f2-ae24-4857cba39b75
- Distribution End Date
- 2020-03-09
Device Description
Non-Stick Pads, all one size, 2 IN x 3 IN
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
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NAC | Dressing, Wound, Hydrophilic | General, Plastic Surgery | 878.4018 | 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. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10041260357104 | GS1 | case | 72 | Not in Commercial Distribution | 2020-03-09 |
| Primary | 00011110351227 | GS1 | ||||
| Unit of Use | 60011110351229 | GS1 |