FDA UDI
In Commercial Distribution
🇺🇸 United States
CARDINAL HEALTH
DI: 00885380027850
·
Model: S1040
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
5
Basic Information
- Brand Name
- CARDINAL HEALTH
- Primary DI
- 00885380027850
- Version / Model
- S1040
- Catalog Number
- S1040
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2019-06-06
- Public Version
- 1
- Public Version Date
- 2019-06-14
- Public Version Status
- New
- Public Device Record Key
- 315f1cf2-9844-4baf-a5e4-bf39a40e8f39
Device Description
Wound Closure Strips; Reinforced; 1/8 in. x 3 in.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NAD | Dressing, wound, occlusive | General, Plastic Surgery | 878.4020 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32207 | Skin-closure adhesive strip | A small, narrow flexible band (of fabric, plastic, paper, or other material) coated on one side with a pressure-sensitive adhesive, used to approximate the edges of superficial wounds. The device may be hypoallergenic and/or waterproof. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50885380027855 | GS1 | CASE | 4 | In Commercial Distribution | |
| Package | 70885380027859 | GS1 | PACK | 50 | In Commercial Distribution | |
| Package | 20885380027854 | GS1 | BOX | 1 | In Commercial Distribution | |
| Primary | 00885380027850 | GS1 | ||||
| Unit of Use | 10885380027857 | GS1 |