FDA UDI
In Commercial Distribution
🇺🇸 United States
Vas-Q-Clip
DI: 10816537020001
·
Model: 2231
·
NANOVA BIO MATERIALS INC
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
6
Basic Information
- Brand Name
- Vas-Q-Clip
- Primary DI
- 10816537020001
- Version / Model
- 2231
- Catalog Number
- 2231
- Company Name
- NANOVA BIO MATERIALS INC
- Labeler DUNS
- 006084093
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2016-07-01
- Public Version
- 4
- Public Version Date
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- 91eccc06-a398-4c9e-81f9-502c2ab58322
Device Description
Medium-Large Ligation Clips 6 Clips/Cart
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
- MR Safe
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- 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
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FZP | CLIP, IMPLANTABLE | General, Plastic Surgery | 878.4300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56711 | Ligation clip, synthetic polymer, non-bioabsorbable | A non-metallic, non-bioabsorbable clasp designed to be implanted around a blood vessel or a tissue bundle for permanent occlusion. It is typically made of plastic materials [e.g., polyoxymethylene (POM), commonly known as Delrin] and may be designed with a self-locking catch. It may be used for ligation in open and endoscopic (e.g., laparoscopic) surgeries, but is usually not intended for fallopian tube occlusion. Its non-metallic design makes it more compatible with radiological imaging than metallic clips. A dedicated, disposable clip applier may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30816537020005 | GS1 | Case | 3 | In Commercial Distribution | |
| Primary | 10816537020001 | GS1 | ||||
| Package | 20816537020008 | GS1 | Box | 14 | In Commercial Distribution | |
| Package | 40816537020002 | GS1 | Case | 12 | In Commercial Distribution | |
| Unit of Use | 00816537020004 | GS1 |
Customer Contacts
- Phone
- +1(573)875-6682
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K151943 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 8.69 | Millimeter |