Duns Number:989365556
Device Description: REEF DEPTH GAUGE
Catalog Number
L93584
Brand Name
REEF
Version/Model Number
L93584
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
HTJ
Product Code Name
GAUGE, DEPTH
Public Device Record Key
95c4078d-3078-4df3-b5b8-342bf8b0a07a
Public Version Date
July 23, 2020
Public Version Number
3
DI Record Publish Date
September 24, 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 | 3549 |
2 | A medical device with a moderate to high risk that requires special controls. | 2188 |
3 | A medical device with high risk that requires premarket approval | 418 |