Duns Number:796416191
Device Description: 2.7mm Depth Gauge, Scale Assembly 10-60mm
Catalog Number
01-9000-2701
Brand Name
2.7mm Depth Gauge, Scale Assembly 10-60mm
Version/Model Number
01-9000-2701
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
e4c3f099-3105-4ca1-975f-01157b35820d
Public Version Date
June 29, 2021
Public Version Number
1
DI Record Publish Date
June 21, 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 | 1662 |
2 | A medical device with a moderate to high risk that requires special controls. | 7273 |