Duns Number:618214410
Device Description: DeBakey Atraumatic Tissue Forceps, 2.0mm wide tips, 7-3/4" (19.5cm), NON-CONDUCTIVE, expos DeBakey Atraumatic Tissue Forceps, 2.0mm wide tips, 7-3/4" (19.5cm), NON-CONDUCTIVE, exposed at both ends
Catalog Number
120-522NC
Brand Name
Hayden Medical
Version/Model Number
120-522NC
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
DWS
Product Code Name
INSTRUMENTS, SURGICAL, CARDIOVASCULAR
Public Device Record Key
661815ba-346a-4d81-a85b-8bcfdef0865f
Public Version Date
August 03, 2022
Public Version Number
1
DI Record Publish Date
July 26, 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 |