FDA UDI
In Commercial Distribution
🇺🇸 United States
WECK
DI: 34026704630401
·
Model: IPN009317
·
TELEFLEX INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
10
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Basic Information
- Brand Name
- WECK
- Primary DI
- 34026704630401
- Version / Model
- IPN009317
- Catalog Number
- 658505
- Company Name
- TELEFLEX INCORPORATED
- Labeler DUNS
- 002348191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2018-05-16
- Public Version
- 2
- Public Version Date
- 2020-01-29
- Public Version Status
- Update
- Public Device Record Key
- 7388b5ff-3d34-4532-b8a9-0c9c4afc5fa5
Device Description
RANEY CLIPS DISPOSABLE 10/pouch
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| HBO | CLIP, SCALP | Neurology | 882.4150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46953 | Scalp wound clip | A small, nonimplantable device in the form of a U-shaped clip that is fired from a dedicated scalp-clip applier (clip gun) or manually applied using dedicated scalp clip forceps, to approximate the margins of a scalp wound/incision associated with a surgical intervention on the cranium/scalp. It is made of metal or plastic materials and is typically applied in rows; it is intended to remain in place until the incision has healed. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 44026704630408 | GS1 | Box | 20 | Not in Commercial Distribution | 2020-01-20 |
| Primary | 34026704630401 | GS1 | ||||
| Package | 54026704630405 | GS1 | Case | 16 | Not in Commercial Distribution | 2020-01-20 |
| Unit of Use | 14026704630407 | GS1 |
Customer Contacts
- Phone
- +1(919)544-8000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 0.625 | Inch |