Duns Number:618214410
Device Description: Laparoscopic DG Retraction Grasper - 5mmD, 36cmL S/A Rotating with Slide Ratchet Handle & Laparoscopic DG Retraction Grasper - 5mmD, 36cmL S/A Rotating with Slide Ratchet Handle & Flush Port (Jarit pattern)
Catalog Number
HE13-1380ADGJ
Brand Name
Hayden Medical
Version/Model Number
HE13-1380ADGJ
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
K974382
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
3c2742c6-6161-49de-a377-464eef250dce
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 |