FDA UDI
In Commercial Distribution
🇺🇸 United States
Titanium Ligation Clip
DI: 40857596005067
·
Model: 50415
·
Vesocclude Medical, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Titanium Ligation Clip
- Primary DI
- 40857596005067
- Version / Model
- 50415
- Catalog Number
- 50415
- Company Name
- Vesocclude Medical, LLC
- Labeler DUNS
- 832920099
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-23
- Public Version
- 4
- Public Version Date
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- 37321c0c-ee08-4fac-9a8a-c2043e4592bb
Device Description
A sterile, metallic, non-bio-absorbable clasp designed to be implanted around a blood vessel, lymphatic vessel, other tubular anatomy, or a tissue bundle for permanent occlusion. It may be used for ligation in open and endoscopic (e.g., laparoscopic) surgeries.
Device Characteristics
- Single Use
- No
- 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
- MR Conditional
- Direct Marking Exempt
- No
- 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
- No
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 |
|---|---|---|---|---|
| 35649 | Ligation clip, metallic | A metallic, non-bioabsorbable clasp designed to be implanted around a blood vessel, lymphatic vessel, other tubular anatomy or a tissue bundle, for permanent occlusion. It may be used for ligation in open and endoscopic (e.g., laparoscopic) surgeries; 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 | 60857596005061 | GS1 | Case | 18 | In Commercial Distribution | |
| Package | 50857596005064 | GS1 | Box | 15 | In Commercial Distribution | |
| Primary | 40857596005067 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K091060 | 000 |