Duns Number:030849173
Device Description: BOJRAB DISSECTION ROUND KNIFE ANGLED 35°, 2.54MM DIA. STAINLESS STEEL
Catalog Number
-
Brand Name
BOJRAB DISSECTION ROUND KNIFE, 2.54MM DIA
Version/Model Number
999-DB8
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
JYO
Product Code Name
Knife, Ear
Public Device Record Key
81a56603-fac9-44f7-91bc-8b375f7a90e9
Public Version Date
April 13, 2021
Public Version Number
1
DI Record Publish Date
April 05, 2021
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 | 200 |
2 | A medical device with a moderate to high risk that requires special controls. | 564 |