Duns Number:633171269
Device Description: ISQ Measurement Peg
Catalog Number
100388
Brand Name
Osstell SmartPeg Type 16
Version/Model Number
Osstell SmartPeg Type 16
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
Yes
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
EKX
Product Code Name
Handpiece, Direct Drive, Ac-Powered
Public Device Record Key
a5cfbdca-55a7-4ddf-ad76-f2bd542d8525
Public Version Date
September 12, 2022
Public Version Number
1
DI Record Publish Date
September 02, 2022
Package DI Number
09010522000168
Quantity per Package
5
Contains DI Package
09010522001301
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 89 |