| Primary Device ID | CP12001 |
| NIH Device Record Key | ac62d7a7-8b3a-49ed-9bf7-6c444925c27f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | rbi2 suction rectal biopsy system |
| Version Model Number | rbi2 |
| Catalog Number | CP1200 |
| Company DUNS | 755219508 |
| Company Name | AUS SYSTEMS PTY. LIMITED. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 |
|---|---|
| HIBCC | CP12001 [Primary] |
| FCK | Instrument, Biopsy, Suction |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[CP12001]
Radiation Sterilization
[CP12001]
Radiation Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-08-29 |
| CP12002 | rbi2 suction rectal biopsy capsules (10 procedure packs) to obtain a submucosal tissue specimen |
| CP12001 | rbi2 suction rectal biopsy procedure pack to obtain a submucosal tissue specimen from the rectum |
| CP12000 | rbi2 suction rectal biopsy capsule to obtain a submucosal tissue specimen from the rectum |
| B194SS10001 | rbi2 suction rectal biopsy system sterilization/storage container |