Duns Number:108999095
Device Description: Medicut Shears,7-1/4", Black, 3/pkg
Catalog Number
320BK-3
Brand Name
MEDICUT
Version/Model Number
320BK-3
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LRW
Product Code Name
Scissors, General, Surgical
Public Device Record Key
02b01783-f412-4eec-afce-ac84696966b7
Public Version Date
August 13, 2018
Public Version Number
1
DI Record Publish Date
July 13, 2018
Package DI Number
00634782595364
Quantity per Package
18
Contains DI Package
00634782895365
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
MASTER PACK
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2395 |
2 | A medical device with a moderate to high risk that requires special controls. | 1769 |