Duns Number:071595540
Device Description: Anchor Tissue Retrieval System™ Bag-Alone® by CONMED
Catalog Number
TRS090
Brand Name
anchor, Bag-Alone
Version/Model Number
TRS090
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
96ac21f0-c26c-49ac-a1fa-769d74daf2f6
Public Version Date
April 23, 2020
Public Version Number
1
DI Record Publish Date
April 15, 2020
Package DI Number
30653405986076
Quantity per Package
5
Contains DI Package
20653405986093
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |