| Primary Device ID | 09340254029541 |
| NIH Device Record Key | 2a8d0f05-c7a2-4b92-8562-fee36b46c084 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TREWAVIS SURGICAL |
| Version Model Number | 501-001-G |
| Catalog Number | 501-001-G |
| Company DUNS | 746296651 |
| Company Name | TREWAVIS SURGICAL INSTRUMENTS 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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 | 09340254029541 [Primary] |
| FFO | Retractor, Self-Retaining |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[09340254029541]
Moist Heat or Steam Sterilization
[09340254029541]
Moist Heat or Steam Sterilization
[09340254029541]
Moist Heat or Steam Sterilization
[09340254029541]
Moist Heat or Steam Sterilization
[09340254029541]
Moist Heat or Steam Sterilization
[09340254029541]
Moist Heat or Steam Sterilization
[09340254029541]
Moist Heat or Steam Sterilization
[09340254029541]
Moist Heat or Steam Sterilization
[09340254029541]
Moist Heat or Steam Sterilization
[09340254029541]
Moist Heat or Steam Sterilization
[09340254029541]
Moist Heat or Steam Sterilization
[09340254029541]
Moist Heat or Steam Sterilization
[09340254029541]
Moist Heat or Steam Sterilization
[09340254029541]
Moist Heat or Steam Sterilization
[09340254029541]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-06-13 |
| Device Publish Date | 2025-06-05 |
| 09340254029442 | MODEL TR RECTAL SUCTION BIOPSY TUBE (INSTRUMENT, BIOPSY, SUCTION) (Rectal Suction Biopsy Tool - |
| 09340254029558 | KEON COHEN RETRACTOR - RIGHT HAND X 100 MM - BARIATRIC |
| 09340254029541 | KEON COHEN RETRACTOR - RIGHT HAND X 80 MM - EXTENDED |
| 09340254029534 | KEON COHEN RETRACTOR - RIGHT HAND X 50 MM |