FDA UDI
Not in Commercial Distribution
🇺🇸 United States
CARDINAL HEALTH
DI: 20885380133838
·
Model: C-SG4412ZS
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
10
Basic Information
- Brand Name
- CARDINAL HEALTH
- Primary DI
- 20885380133838
- Version / Model
- C-SG4412ZS
- Catalog Number
- C-SG4412ZS
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2019-09-11
- Public Version
- 4
- Public Version Date
- 2023-01-02
- Public Version Status
- Update
- Public Device Record Key
- 6cba5bdf-542e-4cd4-8f73-ca5709d6118b
- Distribution End Date
- 2022-12-31
Device Description
-Premium Gauze Sponges -4 x 4 in (10.2 x 10.2 cm) -12-Ply -USP Type VII Gauze
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 |
|---|---|---|---|---|
| 44971 | General-purpose surgical sponge | A non-medicated cushion-like mass made of absorbent materials (e.g., woven gauze, cotton, cellulose) primarily intended to be used inside the body, on a surgical incision or applied to internal organs or structures to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination during a procedure; also referred to as a laparotomy sponge or cottonoid pad/pattie, it may also be used for prepping the patient. It does not contain special features to help detect gossypiboma (sponge left inside patient) [i.e., it is not radiopaque]. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50885380133839 | GS1 | CASE | 2 | Not in Commercial Distribution | 2022-12-31 |
| Package | 30885380133835 | GS1 | BOX | 64 | Not in Commercial Distribution | 2022-12-31 |
| Primary | 20885380133838 | GS1 | ||||
| Unit of Use | 10885380133831 | GS1 |