Primary Device ID | 00850015699016 |
NIH Device Record Key | b62da0e2-9c8e-499c-9df5-2ad7bebedfbf |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | OR Barcode Scanner |
Version Model Number | 43-5570-006-14 |
Company DUNS | 117153396 |
Company Name | Canary Medical USA LLC |
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 | false |
Expiration Date | true |
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 | 00850015699016 [Primary] |
OUG | Medical Device Data System |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-10-07 |
Device Publish Date | 2021-09-29 |
00850015699115 - CanarE Strap | 2023-05-25 |
00850015699122 - Canary Clinic Cart | 2023-05-25 |
00850015699139 - CanarE Charging Cradle | 2023-05-25 |
00860003118344 - CanarE – Clinic Wearable Device | 2023-05-25 |
00860003118368 - Canary Clinic Base Station | 2023-05-25 |
00860003118382 - Clinic Laptop | 2023-05-25 |
00850015699016 - OR Barcode Scanner | 2021-10-07After the surgery is completed, the OR Barcode Scanner can be used to scan the barcodes on the labels of the CTE and other implanted TKA components. |
00850015699016 - OR Barcode Scanner | 2021-10-07 After the surgery is completed, the OR Barcode Scanner can be used to scan the barcodes on the labels of the CTE and other impla |
00860003118337 - OR Laptop | 2021-10-07 Dedicated Laptop PC, part of the OR Base Station System |