Duns Number:078642955
Device Description: DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS
Catalog Number
319.004.EM
Brand Name
EMERGE MEDICAL & Design
Version/Model Number
319.004.EM
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 01, 2018
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
b54c9fd8-0487-4463-b2f4-74603af13f10
Public Version Date
December 07, 2018
Public Version Number
5
DI Record Publish Date
July 08, 2015
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 | 288 |
2 | A medical device with a moderate to high risk that requires special controls. | 1273 |