FDA UDI
In Commercial Distribution
🇺🇸 United States
WECK
DI: 14026704741868
·
Model: IPN924909
·
TELEFLEX INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
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Basic Information
- Brand Name
- WECK
- Primary DI
- 14026704741868
- Version / Model
- IPN924909
- Catalog Number
- AE05ML
- Company Name
- TELEFLEX INCORPORATED
- Labeler DUNS
- 002348191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-10-02
- Public Version
- 1
- Public Version Date
- 2025-10-10
- Public Version Status
- New
- Public Device Record Key
- 323380be-cca7-4da9-bb47-86fe528bd17f
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
- Labeling does not contain MRI Safety Information
- 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 |
|---|---|---|---|---|
| 65721 | Endoscopic surgical ligation clip applier, single-use | A hand-held manual surgical instrument intended to be used during an endoscopic (e.g., laparoscopic) surgical procedure to apply small atraumatic clips (not included) for the ligation of blood vessels, or similar tubular anatomy, mainly to prevent and/or stop bleeding (i.e., haemostasis). It is neither designed to apply aneurysm clips nor gastrointestinal clips. It typically includes distal jaws, a slender shaft, and a proximal handle (e.g., trigger-like). The ligation clips are not included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 24026704741865 | GS1 | 1 | In Commercial Distribution | ||
| Primary | 14026704741868 | GS1 | ||||
| Package | 34026704741862 | GS1 | Box | 3 | In Commercial Distribution | |
| Package | 44026704741869 | GS1 | Case | 6 | In Commercial Distribution | |
| Previous | 24026704695892 | GS1 |
Customer Contacts
- Phone
- +1(919)544-8000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K230480 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 35 | Centimeter |