FDA UDI
Not in Commercial Distribution
🇺🇸 United States
CARDINAL HEALTH
DI: 20885380133807
·
Model: C-SG44122E
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
25
Basic Information
- Brand Name
- CARDINAL HEALTH
- Primary DI
- 20885380133807
- Version / Model
- C-SG44122E
- Catalog Number
- C-SG44122E
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2019-06-27
- Public Version
- 4
- Public Version Date
- 2023-01-02
- Public Version Status
- Update
- Public Device Record Key
- c712b34b-17d8-4165-8d87-8eea8fdcf251
- Distribution End Date
- 2022-12-31
Device Description
GAUZE SPONGE-STANDARD 4X4 12PLY ST
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
- 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
- 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 |
|---|---|---|---|---|
| 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. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30885380133804 | GS1 | BOX | 25 | Not in Commercial Distribution | 2022-12-31 |
| Primary | 20885380133807 | GS1 | ||||
| Package | 50885380133808 | GS1 | CASE | 24 | Not in Commercial Distribution | 2022-12-31 |
| Unit of Use | 10885380133800 | GS1 |