FDA UDI
In Commercial Distribution
🇺🇸 United States
TREWAVIS SURGICAL
DI: 09340254000632
·
Model: SBT100
·
TREWAVIS SURGICAL INSTRUMENTS PTY LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TREWAVIS SURGICAL
- Primary DI
- 09340254000632
- Version / Model
- SBT100
- Catalog Number
- 100-010-00
- Company Name
- TREWAVIS SURGICAL INSTRUMENTS PTY LTD
- Labeler DUNS
- 746296651
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-20
- Public Version
- 4
- Public Version Date
- 2019-07-12
- Public Version Status
- Update
- Public Device Record Key
- 2f03f6d8-e1af-41c7-aea4-4c0efaeb3ba6
Device Description
MODEL TR RECTAL SUCTION BIOPSY TUBE (INSTRUMENT, BIOPSY, SUCTION) (Rectal Suction Biopsy Tool)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FCK | Instrument, Biopsy, Suction | Gastroenterology, Urology | 876.1075 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11775 | Open-surgery biopsy forceps, reusable | A hand-held manual surgical instrument designed to obtain soft-tissue biopsy specimens from an open surgical wound or from within/near a large natural orifice (e.g., vagina, rectum) for histopathological examination; it is not intended for endoscopic or catheterized access. It is a metallic forceps-like instrument with a distal mechanism designed to bite/punch the biopsy sample and hold it for extraction when the handles are squeezed together. It is not designed for cutting bone (i.e., not a rongeur). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09340254000632 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K902097 | 000 |