FDA UDI
In Commercial Distribution
🇺🇸 United States
WECK
DI: 04026704599745
·
Model: IPN006431
·
TELEFLEX INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
6
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Basic Information
- Brand Name
- WECK
- Primary DI
- 04026704599745
- Version / Model
- IPN006431
- Catalog Number
- 382800
- Company Name
- TELEFLEX INCORPORATED
- Labeler DUNS
- 002348191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2018-05-15
- Public Version
- 2
- Public Version Date
- 2020-01-29
- Public Version Status
- Update
- Public Device Record Key
- 1b29b69f-3560-469a-9eef-c983504f5fa5
Device Description
DURAHOOK 1/4 HOOK 10 PACKAGES PER BOX /6 HOOKS PER PACKAGE
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HAO | INSTRUMENT, SURGICAL, NON-POWERED | Neurology | 882.4535 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47991 | Self-retaining surgical retractor, single-use | A sterile, hand-operated, self-retaining, one-piece surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 44026704599743 | GS1 | Case | 10 | Not in Commercial Distribution | 2020-01-20 |
| Package | 24026704599749 | GS1 | Box | 60 | Not in Commercial Distribution | 2020-01-20 |
| Primary | 04026704599745 | GS1 | ||||
| Unit of Use | 14026704599742 | GS1 |
Customer Contacts
- Phone
- +1(919)544-8000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 0.25 | Inch | |
| Length | 4.5 | Inch |