Duns Number:087844537
Device Description: Flick-Catcher® Basket Pair, Short(Contains 1 each of 00850013858040 and 00850013858057)
Catalog Number
SP-XSB-001
Brand Name
Flick-Catcher®
Version/Model Number
SP-XSB-001
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
FZT
Product Code Name
Cutter, Surgical
Public Device Record Key
62e5b2f7-119d-4c09-8572-26c8c26a3bbe
Public Version Date
March 09, 2022
Public Version Number
1
DI Record Publish Date
March 01, 2022
Package DI Number
10850013858115
Quantity per Package
5
Contains DI Package
00850013858118
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 11 |