Duns Number:645681094
Device Description: FOERSTER Sponge Forceps, Serrated, Straight, 9-1/2"
Catalog Number
14-256
Brand Name
CROWN SURGICAL
Version/Model Number
FORCEPS
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
GEN
Product Code Name
Forceps, General & Plastic Surgery
Public Device Record Key
0be4deb6-56bc-49b6-865f-d71e940d8d82
Public Version Date
March 11, 2021
Public Version Number
1
DI Record Publish Date
March 03, 2021
Package DI Number
B924142562
Quantity per Package
250
Contains DI Package
B924142560
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 |