Duns Number:190572854
Device Description: CORDCUTTER - Reusable Suture Cutter
Catalog Number
214646
Brand Name
NA
Version/Model Number
214646
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)
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
2e01b8d4-3c02-448a-8faa-6c6f78f8ef1c
Public Version Date
June 26, 2018
Public Version Number
3
DI Record Publish Date
September 01, 2015
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 | 560 |
2 | A medical device with a moderate to high risk that requires special controls. | 479 |