| Primary Device ID | 09349797000093 |
| NIH Device Record Key | d0dce5b3-47bb-48e2-bc06-19a7423593b4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Surgical Template |
| Version Model Number | TP-BRT |
| Catalog Number | TP-BRT |
| Company DUNS | 755739307 |
| Company Name | ANATOMICS PTY 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | 09349797000093 [Primary] |
| HWT | Template |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-12-04 |
| Device Publish Date | 2020-11-26 |
| 09349797000093 - Surgical Template | 2020-12-04Surgical Template - BRT |
| 09349797000093 - Surgical Template | 2020-12-04 Surgical Template - BRT |
| 09349797002530 - StarPore | 2020-04-13 StarPore Patient Specific Implant (Small) |
| 09349797002547 - StarPore | 2020-04-13 StarPore Patient Specific Implant (Medium) |
| 09349797002554 - StarPore | 2020-04-13 StarPore Patient Specific Implant (Large) |
| 09349797002561 - StarPore | 2020-04-13 StarPore Patient Specific Implant (X-Large) |
| 09349797001700 - StarPore | 2020-02-25 StarPore Patient Specific Implant |
| 09349797002387 - StarPore | 2020-02-18 StarPore Patient Specific Implant (SAMPLE) |
| 09349797000192 - StarPore | 2020-01-16 StarPore Patient Specific Implant (Small) |