Duns Number:212397483
Device Description: Suture cutter. A dedicated hand held surgical instrument used for cutting sutures. It will Suture cutter. A dedicated hand held surgical instrument used for cutting sutures. It will typically have a protected scalpel like blade which may be fixed or have a scissor cutting action.
Catalog Number
P420
Brand Name
Swann Morton Ltd.
Version/Model Number
PARAGON STITCH CUTTER
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)
-
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
358abd63-6ee1-40dc-95e2-ab14582b6e04
Public Version Date
June 07, 2022
Public Version Number
1
DI Record Publish Date
May 30, 2022
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 | 412 |