Duns Number:353939929
Device Description: Pos Loc Multiple Strmn BLvl RC4.1/4.8
Catalog Number
300494
Brand Name
NA
Version/Model Number
300494
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
NDP
Product Code Name
Accessories, implant, dental, endosseous
Public Device Record Key
c611260f-a187-456e-a68d-7aaf9af810f2
Public Version Date
August 01, 2022
Public Version Number
1
DI Record Publish Date
July 22, 2022
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 | 782 |
2 | A medical device with a moderate to high risk that requires special controls. | 3680 |