Duns Number:645681094
Device Description: IRIS Scissors, Straight, 4-1/2" PP BULK
Catalog Number
11-138-PP
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
2e4469fc-2db0-43ca-82b5-0a6114063364
Public Version Date
September 23, 2022
Public Version Number
2
DI Record Publish Date
February 28, 2021
Package DI Number
B92411138PP2
Quantity per Package
1000
Contains DI Package
B92411138PP0
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 |