Duns Number:117559084
Device Description: Stumpel Voss Blakesley Pediatric Forcep 45 degree upturn
Catalog Number
10-15296
Brand Name
Aztec
Version/Model Number
10-15296
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
KAE
Product Code Name
Forceps, Ent
Public Device Record Key
8c821084-531d-468c-ab8d-f1219f671be8
Public Version Date
October 14, 2020
Public Version Number
1
DI Record Publish Date
October 06, 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 | 189 |