Duns Number:746296651
Device Description: MODEL TR RECTAL SUCTION BIOPSY TUBE (INSTRUMENT, BIOPSY, SUCTION) (Rectal Suction Biopsy T MODEL TR RECTAL SUCTION BIOPSY TUBE (INSTRUMENT, BIOPSY, SUCTION) (Rectal Suction Biopsy Tool)
Catalog Number
100-010-00
Brand Name
TREWAVIS SURGICAL
Version/Model Number
SBT100
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K902097
Product Code
FCK
Product Code Name
Instrument, Biopsy, Suction
Public Device Record Key
2f03f6d8-e1af-41c7-aea4-4c0efaeb3ba6
Public Version Date
July 12, 2019
Public Version Number
4
DI Record Publish Date
October 20, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |