Duns Number:024328124
Device Description: Debakey Tissue Forceps Insulated, 9.5" (24.1cm), 1.5mm Jaw, Stainless Steel
Catalog Number
G64-009I
Brand Name
STINGRAY SURGICAL PRODUCTS
Version/Model Number
G64-009I
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"
Yes
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
HTD
Product Code Name
Forceps
Public Device Record Key
8a81bb01-2ff1-4bca-8085-2e54536d62e0
Public Version Date
May 28, 2021
Public Version Number
1
DI Record Publish Date
May 20, 2021
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 | 133 |
2 | A medical device with a moderate to high risk that requires special controls. | 4643 |