Duns Number:107105876
Device Description: MODIFIED INSTRUMENT ROD GAUGE
Catalog Number
698341752
Brand Name
NA
Version/Model Number
698341752
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
HTJ
Product Code Name
GAUGE, DEPTH
Public Device Record Key
0f7f9afd-b478-4abe-8aa2-e17a77e56e4e
Public Version Date
December 07, 2018
Public Version Number
3
DI Record Publish Date
November 11, 2016
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 | 5839 |
2 | A medical device with a moderate to high risk that requires special controls. | 2784 |
U | Unclassified | 20 |