Primary Device ID | 07290019087113 |
NIH Device Record Key | aececf46-229c-44b9-9865-06ed6466f520 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Agili-C Quick Connect Handle |
Version Model Number | RU-QCH |
Company DUNS | 533214388 |
Company Name | CARTIHEAL (2009) LTD |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07290019087113 [Primary] |
QBO | Instruments Designed For Press-Fit Osteochondral Implants |
Steralize Prior To Use | true |
Device Is Sterile | false |
[07290019087113]
Moist Heat or Steam Sterilization
[07290019087113]
Moist Heat or Steam Sterilization
[07290019087113]
Moist Heat or Steam Sterilization
[07290019087113]
Moist Heat or Steam Sterilization
[07290019087113]
Moist Heat or Steam Sterilization
[07290019087113]
Moist Heat or Steam Sterilization
[07290019087113]
Moist Heat or Steam Sterilization
[07290019087113]
Moist Heat or Steam Sterilization
[07290019087113]
Moist Heat or Steam Sterilization
[07290019087113]
Moist Heat or Steam Sterilization
[07290019087113]
Moist Heat or Steam Sterilization
[07290019087113]
Moist Heat or Steam Sterilization
[07290019087113]
Moist Heat or Steam Sterilization
[07290019087113]
Moist Heat or Steam Sterilization
[07290019087113]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-10-12 |
Device Publish Date | 2022-10-04 |
07290019087199 - Agili-C Surgical Toolset Full Sterilization Tray | 2023-12-11 Agili-C Surgical Toolset Full Sterilization Tray |
07290019087168 - Agili-C | 2023-06-08 2X Agili-C D7.5 Implant Pack |
07290019087175 - Agili-C | 2023-06-08 3X Agili-C D7.5 Implant Pack |
07290019087182 - Agili-C | 2023-06-08 5X Agili-C D7.5 Implant |
07290019087007 - Agili-C | 2022-10-12 Agili-C Implant Diameter 7.5mm Length 10mm |
07290019087014 - Agili-C | 2022-10-12 Agili-C Implant Diameter 10mm, Length 10mm |
07290019087021 - Agili-C | 2022-10-12 Agili-C Implant Diameter 12.5mm, Length 10mm |
07290019087038 - Agili-C | 2022-10-12 Agili-C Implant Diameter 15mm , Length 10mm |