Duns Number:211167885
Device Description: DEPTH GAUGE INNER BODY WITH BALL & SPRING. THIS INNER TUBE HAS MARKINGS ON IT. IT SITS INS DEPTH GAUGE INNER BODY WITH BALL & SPRING. THIS INNER TUBE HAS MARKINGS ON IT. IT SITS INSIDE THE "DEPTH GAUGE OUTER BODY TUBE - RM06008 (DI NO# 05060433906)". THIS CREATES THE FINAL INSTRUMENT IN626/1 - "DEPTH GAUGE ASSEMBLY - AS01069"
Catalog Number
RM06009
Brand Name
LSSS
Version/Model Number
RM06009
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EIL
Product Code Name
Gauge, Depth, Instrument, Dental
Public Device Record Key
1944352d-604c-4c4e-af00-649aa01a2607
Public Version Date
August 03, 2020
Public Version Number
1
DI Record Publish Date
July 24, 2020
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 | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 31 |