Duns Number:123551586
Device Description: Biopsy Forceps, 3.0mm Double-Spoon, 70 Degree, Vertical
Catalog Number
7.54.34V
Brand Name
BEAR
Version/Model Number
7.54.34V
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
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KAE
Product Code Name
Forceps, Ent
Public Device Record Key
f6c5c9db-d625-445e-b143-9890c670b8c7
Public Version Date
June 21, 2022
Public Version Number
1
DI Record Publish Date
June 12, 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 | 524 |
2 | A medical device with a moderate to high risk that requires special controls. | 21 |