Duns Number:645829172
Device Description: 15.5 cm Jaw 7.5 mm
Catalog Number
26-0235
Brand Name
Bluemed Surgical
Version/Model Number
Kern Bone Holding Forcep
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HTD
Product Code Name
Forceps
Public Device Record Key
cf47026b-36ac-4b25-aeeb-149c4460068b
Public Version Date
August 02, 2022
Public Version Number
1
DI Record Publish Date
July 25, 2022
Package DI Number
G0332602351
Quantity per Package
20
Contains DI Package
G0332602350
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Poly Bag
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1 |