Duns Number:047063695
Device Description: L Hook for Bovie Pencil Handle
Catalog Number
OS-L-Hook-33-5-B
Brand Name
L Hook for Bovie Pencil Handle
Version/Model Number
OS-L-Hook-33-5-B
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
afdcc39f-608e-47f7-afc3-46d1a0cdb38f
Public Version Date
August 17, 2021
Public Version Number
4
DI Record Publish Date
November 14, 2016
Package DI Number
B354OSLHOOK335B10
Quantity per Package
10
Contains DI Package
B354OSLHOOK335B0
Package Discontinue Date
November 14, 2019
Package Status
Not in Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 6 |
2 | A medical device with a moderate to high risk that requires special controls. | 271 |