Duns Number:071595540
Device Description: TISSUE RETRIEVAL SYSTEM, 15MM, 1800ML (3/BX)
Catalog Number
TRS190SB2
Brand Name
ANCHOR TISSUE RETRIEVAL SYSTEM
Version/Model Number
TRS190SB2
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
1c5e99f3-e1d3-469f-b3a2-7250ba0256c5
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 06, 2018
Package DI Number
30653405986137
Quantity per Package
3
Contains DI Package
20653405986130
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 |