Duns Number:645681094
Device Description: Operating Scissors, Straight, Sharp/Blunt, 5-1/2"
Catalog Number
11-107-SB-DB
Brand Name
CROWN SURGICAL
Version/Model Number
SCISSORS
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
LRW
Product Code Name
Scissors, General, Surgical
Public Device Record Key
d1cf9e64-4187-4033-9134-0595f092e435
Public Version Date
September 23, 2022
Public Version Number
2
DI Record Publish Date
March 05, 2021
Package DI Number
B92411107SBDB2
Quantity per Package
300
Contains DI Package
B92411107SBDB0
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CARDBOARD BOX
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2 |