Duns Number:322018193
Device Description: CAMLOG® Guiding pin for bone profiler for Ø 3.3 mm, titanium alloy
Catalog Number
J5002.3300
Brand Name
CAMLOG® Guiding pin for bone profiler
Version/Model Number
J5002.3300
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
NDP
Product Code Name
Accessories, Implant, Dental, Endosseous
Public Device Record Key
7fed81e8-8617-49fd-9ed2-1a0af7fbae21
Public Version Date
January 09, 2020
Public Version Number
2
DI Record Publish Date
December 31, 2018
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 | 290 |
2 | A medical device with a moderate to high risk that requires special controls. | 901 |