| Primary Device ID | 00810072350862 |
| NIH Device Record Key | efc6791a-11fa-404e-8120-0c9d1d57ac60 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Donor template |
| Version Model Number | Donor template |
| Catalog Number | 400.000 |
| Company DUNS | 078573265 |
| Company Name | Cole Instruments Inc |
| 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 | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810072350862 [Primary] |
| HWT | Template |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-12-22 |
| Device Publish Date | 2021-12-14 |
| 00810072351159 - Graft Storage Plate | 2023-11-03 A plate that cools and holds follicles until the follicles are ready for donation on the recipient area of the human forhead. |
| 00810072351142 - ATOE-Stainless Steel | 2022-08-05 Aide To Extraction (ATOE), made of stainless steel. Used in extracting follicles after being punches. |
| 00810072350831 - Tweezers | 2021-12-22 Tweezers |
| 00810072350862 - Donor template | 2021-12-22Donor template |
| 00810072350862 - Donor template | 2021-12-22 Donor template |
| 00810072350879 - AHSAD | 2021-12-22 Assist to Hairline Surface Area Determination. Can assist in surface for donor or receipient area. |
| 00810072350947 - Graft Board Round LED Backlight | 2021-12-22 Round LED back light used for Graft Boards in processing |
| 00810072350954 - Graft Cleaning Bowl | 2021-12-22 Graft cleaning bowl used in the cleaning of follicles removed from the donor area before they are entered into the recipient are |
| 00810072350008 - 1.30 mm regular punch, 5 pack | 2021-02-12 1.30 mm regular punch, 5 pack |