FDA UDI
In Commercial Distribution
🇺🇸 United States
WECK
DI: 14026704553133
·
Model: IPN010798
·
TELEFLEX INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- WECK
- Primary DI
- 14026704553133
- Version / Model
- IPN010798
- Catalog Number
- AE10LG
- Company Name
- TELEFLEX INCORPORATED
- Labeler DUNS
- 002348191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-12
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- bffd2c48-1793-42c0-b2db-71cba2a29689
Device Description
AUTOMATIC ENDOSCOPIC 10 LARGE
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 Safe
- 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 |
|---|---|---|---|---|
| 58040 | Laparoscopic clip applier | A sterile, rigid device designed to perform through a compatible laparoscopic instrument (e.g., a laparoscopic sleeve) for the application of an implantable clip(s), to achieve ligation/occlusion during transection or for radiographic marking. It typically consists of an insertion sheath, a mechanism at the distal end for applying the clips, an integral cassette containing the surgical or ligation clips, and a control handle at the proximal end for firing the clips into the target tissue. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 44026704553134 | GS1 | Case | 6 | In Commercial Distribution | |
| Package | 24026704553130 | GS1 | Box | 3 | In Commercial Distribution | |
| Package | 04026704553136 | GS1 | Box | 1 | In Commercial Distribution | |
| Primary | 14026704553133 | GS1 |
Customer Contacts
- Phone
- +1(919)544-8000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K161758 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 35 | Centimeter | |
| Outer Diameter | 10 | Millimeter |