FDA UDI
Not in Commercial Distribution
🇺🇸 United States
CARDINAL HEALTH
DI: 20885380066631
·
Model: C-NSG448E
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
200
Basic Information
- Brand Name
- CARDINAL HEALTH
- Primary DI
- 20885380066631
- Version / Model
- C-NSG448E
- Catalog Number
- C-NSG448E
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 200
- Record Status
- Published
- Publish Date
- 2019-09-11
- Public Version
- 3
- Public Version Date
- 2023-01-02
- Public Version Status
- Update
- Public Device Record Key
- 19676d3a-b1ce-498f-918e-44209b4951ea
- Distribution End Date
- 2022-12-31
Device Description
-Gauze Sponges -4 x 4 in (10.2 x 10.2 cm) -8-Ply -Woven 100% Cotton
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
- 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 |
|---|---|---|---|---|
| 48133 | Woven gauze pad, non-sterile | A non-medicated, non-sterile 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 cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates, or to apply topical medications. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50885380066632 | GS1 | CASE | 20 | Not in Commercial Distribution | 2022-12-31 |
| Primary | 20885380066631 | GS1 | ||||
| Unit of Use | 00885380066637 | GS1 |