Duns Number:618214410
Device Description: Agris-Dingman Transauxillary Breast Dissectors 15-3/4" (39.4cm), graduated in CM's, pair - Agris-Dingman Transauxillary Breast Dissectors 15-3/4" (39.4cm), graduated in CM's, pair - left/right
Catalog Number
405-710
Brand Name
Hayden Medical
Version/Model Number
405-710
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
GDI
Product Code Name
DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY
Public Device Record Key
713e62f8-3cc3-43a7-a5be-bf42b8e6f57e
Public Version Date
September 20, 2022
Public Version Number
1
DI Record Publish Date
September 12, 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 | 2893 |
2 | A medical device with a moderate to high risk that requires special controls. | 195 |