TREWAVIS SURGICAL
- Primary DI
- 09340254000632
- Brand
- TREWAVIS SURGICAL
- Company
- TREWAVIS SURGICAL INSTRUMENTS PTY LTD
- Model
- SBT100
- Catalog number
- 100-010-00
- Device description
- MODEL TR RECTAL SUCTION BIOPSY TUBE (INSTRUMENT, BIOPSY, SUCTION) (Rectal Suction Biopsy Tool)
- Published
- 2016-10-20
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
Product Codes#
| Code | Name |
|---|---|
| FCK | Instrument, Biopsy, Suction |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| FCK | Instrument, Biopsy, Suction | Gastroenterology, Urology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K902097 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 09340254000632 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 09340254000632 | 09340254000632 | 9340254000632 |
Sterilization Methods#
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags#
- DUNS number
- 746296651
- Device count
- 1
- Lot or batch
- true
- Serial number
- true
- Expiration date on label
- true
- Sterilization required before use
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 09340254029534 | TREWAVIS SURGICAL | 501-001-B | 501-001-B | 2025-06-05 |
| 09340254029541 | TREWAVIS SURGICAL | 501-001-G | 501-001-G | 2025-06-05 |
| 09340254029558 | TREWAVIS SURGICAL | 501-001-S | 501-001-S | 2025-06-05 |
| 09340254029442 | TREWAVIS SURGICAL | SBT 200 | SBT 200 | 2022-10-13 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00853277008084 | LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) | UVISION 360, INC. | FCK | 2021-08-13 |
| 00853277008091 | LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) | UVISION 360, INC. | FCK | 2021-08-13 |
| B194HP10001 | rbi2 suction rectal biopsy system | AUS SYSTEMS PTY. LIMITED. | FCK | 2016-10-24 |
| B194SS10001 | rbi2 suction rectal biopsy system | AUS SYSTEMS PTY. LIMITED. | FCK | 2016-10-24 |
| 00827002217911 | Howell | COOK INCORPORATED | FCK | 2016-09-24 |
| B194CP12001 | rbi2 suction rectal biopsy system | AUS SYSTEMS PTY. LIMITED. | FCK | 2016-08-29 |
| B194MR1001 | rbi2 suction rectal biopsy system | AUS SYSTEMS PTY. LIMITED. | FCK | 2016-08-29 |
| CP12000 | rbi2 suction rectal biopsy system | AUS SYSTEMS PTY. LIMITED. | FCK | 2016-08-29 |
| CP12001 | rbi2 suction rectal biopsy system | AUS SYSTEMS PTY. LIMITED. | FCK | 2016-08-29 |
| CP12002 | rbi2 suction rectal biopsy system | AUS SYSTEMS PTY. LIMITED. | FCK | 2016-08-29 |