FDA UDI
In Commercial Distribution
🇺🇸 United States
Plate Holder Pin
DI: 09120069812879
·
Model: 62511
·
I.T.S. GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Plate Holder Pin
- Primary DI
- 09120069812879
- Version / Model
- 62511
- Catalog Number
- 62511
- Company Name
- I.T.S. GmbH
- Labeler DUNS
- 303456917
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-13
- Public Version
- 2
- Public Version Date
- 2024-10-01
- Public Version Status
- Update
- Public Device Record Key
- c1099368-ae18-4e11-9be8-e0867ab2ef14
Device Description
Plate Holder Pin, PROlock Radius Plate
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- 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
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HWC | Screw, Fixation, Bone | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47874 | Orthopaedic ball spike | A hand-held manual surgical instrument used in the surgical wound to reposition a bone fragment during a surgical intervention. It is typically a robust instrument designed with a handle at the proximal end and a long, sturdy, shaft that terminates in a singularly pointed ball head at the distal end. It is typically made of high-grade stainless steel and/or synthetic material and is used by the surgeon to reposition and hold bone fragments. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09120069812879 | GS1 |