FDA UDI
In Commercial Distribution
🇺🇸 United States
V-Close
DI: 00860011629412
·
Model: VC
·
DRS Vascular, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
6
Basic Information
- Brand Name
- V-Close
- Primary DI
- 00860011629412
- Version / Model
- VC
- Company Name
- DRS Vascular, Inc.
- Labeler DUNS
- 119066556
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2026-03-09
- Public Version
- 1
- Public Version Date
- 2026-03-17
- Public Version Status
- New
- Public Device Record Key
- 34c7cb6f-9a1b-42a6-8535-cca25209a6ab
Device Description
The device is designed to be placed temporarily over a skin incision to assist with holding suture tension prior to final closure.
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
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KGS | Retention Device, Suture | General, Plastic Surgery | 878.4930 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33519 | Suture retention device | A device designed to be placed on the surface of the skin and intended to aid wound healing by distributing suture tension over a larger area in the patient. It is typically in the form of a retention bridge, a surgical button, or a suture bolster through which the sutures are passed. The distribution of suture tension will help prevent the suture from cutting the skin. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 10860011629419 | GS1 | ||||
| Primary | 00860011629412 | GS1 |
Customer Contacts
- Phone
- 510-345-7233
- [email protected]