FDA UDI
In Commercial Distribution
🇺🇸 United States
MATIRA ANTERIOR CERVICAL SYSTEM
DI: B07307K0130201
·
Model: 07-K01-3020
·
Kalitec Direct LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- MATIRA ANTERIOR CERVICAL SYSTEM
- Primary DI
- B07307K0130201
- Version / Model
- 07-K01-3020
- Catalog Number
- 07-K01-3020
- Company Name
- Kalitec Direct LLC
- Labeler DUNS
- 041956211
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-10-31
- Public Version
- 3
- Public Version Date
- 2020-01-10
- Public Version Status
- Update
- Public Device Record Key
- 52af49bf-8c3c-4b3f-ab8e-a3375ae0f930
Device Description
PLATE CALIPER
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
- 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 |
|---|---|---|---|---|
| KTZ | Caliper | Orthopedic | 888.4150 | 1 |
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 | B07307K0130201 | HIBCC |