Duns Number:081277700
Device Description: Atraumatic Babcock Grasping Forceps, 5mm Outer Diameter, 35cm Working length, Dual Action Atraumatic Babcock Grasping Forceps, 5mm Outer Diameter, 35cm Working length, Dual Action Jaws, Ratchet Handle with Rotation
Catalog Number
35-105
Brand Name
Integra® Miltex®
Version/Model Number
35-105
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 01, 2022
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
NWV
Product Code Name
Laparoscopic accessories, gynecologic
Public Device Record Key
78455a3d-8733-4dad-921c-406f9955550a
Public Version Date
July 15, 2022
Public Version Number
4
DI Record Publish Date
October 23, 2018
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 | 15051 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4286 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 3 |