FDA UDI
In Commercial Distribution
🇺🇸 United States
VICKERS K-WIRE PIN BENDER
DI: 00192896088535
·
Model: 1103-178A
·
SONTEC INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VICKERS K-WIRE PIN BENDER
- Primary DI
- 00192896088535
- Version / Model
- 1103-178A
- Catalog Number
- 1103-178A
- Company Name
- SONTEC INSTRUMENTS, INC.
- Labeler DUNS
- 040729840
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-11
- Public Version
- 3
- Public Version Date
- 2020-03-10
- Public Version Status
- Update
- Public Device Record Key
- 5efdb859-d902-4ab3-9d52-caabbb5f1f47
Device Description
VICKERS K-WIRE PIN BENDER BLACK COATED
Device Characteristics
- Single Use
- No
- 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
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- ["Dry Heat Sterilization", "Moist Heat or Steam Sterilization"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GFC | DRIVER, SURGICAL, PIN | General, Plastic Surgery | 878.4820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44795 | Manual orthopaedic bender, reusable | A manually-operated surgical instrument designed to bend orthopaedic devices, typically those for implantation (e.g., orthopaedic rods, bone fixation plates), to an appropriate anatomical shape. The bending process is typically performed within the operating room (OR), inside or outside of the operative sterile field. The device may be hand held or table mounted. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00192896088535 | GS1 |
Customer Contacts
- Phone
- +1(800) 821-7496
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 3.5 | Inch | |
| Device Size Text, specify | 1 x 1.2 Millimeter Diameter |