FDA UDI
In Commercial Distribution
🇺🇸 United States
WECK
DI: 34026704624806
·
Model: IPN028172
·
TELEFLEX INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
6
Basic Information
- Brand Name
- WECK
- Primary DI
- 34026704624806
- Version / Model
- IPN028172
- Catalog Number
- 003200
- Company Name
- TELEFLEX INCORPORATED
- Labeler DUNS
- 002348191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2018-09-27
- Public Version
- 7
- Public Version Date
- 2022-05-16
- Public Version Status
- Update
- Public Device Record Key
- 92d07ea6-3f37-4104-a201-3c41d5edfdea
Device Description
HORIZON TI ML 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 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 | 54026704624800 | GS1 | Case | 12 | Not in Commercial Distribution | 2022-04-26 |
| Package | 44026704624803 | GS1 | Box | 20 | Not in Commercial Distribution | 2022-04-26 |
| Primary | 34026704624806 | GS1 | ||||
| Unit of Use | 14026704624802 | GS1 | ||||
| Previous | 14026704410269 | GS1 |
Customer Contacts
- Phone
- +1(919)544-8000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K982313 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 7.21 | Millimeter | |
| Length | 8.98 | Millimeter | |
| Device Size Text, specify | Horizon Medium-Large Ligating Clips, Single Pack, Titanium |