Duns Number:212397483
Device Description: A sterile, hand held, manual surgical instrument constructed as a one piece handle and sca A sterile, hand held, manual surgical instrument constructed as a one piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade is typically made of high grade stainless steel alloy or carbon steel and the handle is often made of plastic. This is a single use device.
Catalog Number
P592
Brand Name
Swann Morton Ltd.
Version/Model Number
PARAGON No. 15T STERILE DISPOSABLE SCALPELS
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
GDX
Product Code Name
Scalpel, One-Piece
Public Device Record Key
51012ab9-b4d6-4eed-9576-6652d3cec5c7
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 |