Duns Number:100512072
Device Description: DELTA XTEND™ Humeral Rasp 12 mm
Catalog Number
T10722
Brand Name
Viant Medical, LLC
Version/Model Number
T10722
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
HTR
Product Code Name
Rasp
Public Device Record Key
cd9fa162-7f55-4e70-b11a-578c73a20e5a
Public Version Date
October 07, 2020
Public Version Number
1
DI Record Publish Date
September 29, 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 | 967 |