FDA UDI
Not in Commercial Distribution
🇺🇸 United States
SLS-CLIP
DI: 03661624000219
·
Model: O4120-1
·
VITALITEC SURGICAL
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- SLS-CLIP
- Primary DI
- 03661624000219
- Version / Model
- O4120-1
- Catalog Number
- O4120-1
- Company Name
- VITALITEC SURGICAL
- Labeler DUNS
- 262783206
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-17
- Public Version
- 4
- Public Version Date
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- 56c2be2c-40b8-458a-a1ce-afe1d645af85
- Distribution End Date
- 2016-06-01
Device Description
Titanium Hemostatic Clip - Large Size
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
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 | 03661624006426 | GS1 | grouping carton | 44 | Not in Commercial Distribution | 2016-06-01 |
| Package | 03661624000226 | GS1 | clinical box | 20 | Not in Commercial Distribution | 2016-06-01 |
| Primary | 03661624000219 | GS1 |
Customer Contacts
- Phone
- 508-7476033
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 12.3 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store the unopened sterile package in a cool, dry area, with good ventilation away from areas of extreme temperature and humidity.