FDA UDI
In Commercial Distribution
🇺🇸 United States
KONG-TL VBR System, Implant Height Forceps
DI: 07640164847801
·
Model: 44-010
·
icotec AG
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- KONG-TL VBR System, Implant Height Forceps
- Primary DI
- 07640164847801
- Version / Model
- 44-010
- Catalog Number
- 44-010
- Company Name
- icotec AG
- Labeler DUNS
- 480789465
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-19
- Public Version
- 3
- Public Version Date
- 2025-08-07
- Public Version Status
- Update
- Public Device Record Key
- afd41f23-8823-4012-a9bb-b9aefe85f294
Device Description
KONG-TL VBR System, Implant Height Forceps
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| MQP | Spinal Vertebral Body Replacement Device | Orthopedic | 888.3060 | 2 |
| PLR | Spinal Vertebral Body Replacement Device - Cervical | Orthopedic | 888.3060 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35788 | Orthopaedic bone calliper | A hand-held manual surgical instrument consisting of two legs hinged at one end designed to measure various bone dimensions (e.g., diameter or length) required for orthopaedic procedures. It has an attached scale to indicate the measured units. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07640164847801 | GS1 |
Customer Contacts
- Phone
- +41717570000
- [email protected]