Duns Number:081277700
Device Description: Parallel Pliers, 7-1/4", Grooved 10mm Jaws For, Pin Removal, With Side Cutter, 1.6mm Maxim Parallel Pliers, 7-1/4", Grooved 10mm Jaws For, Pin Removal, With Side Cutter, 1.6mm Maximum
Catalog Number
275-561
Brand Name
Integra® Jarit®
Version/Model Number
275561
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
HTC
Product Code Name
PLIERS, SURGICAL
Public Device Record Key
6bff2c5e-34c7-47a2-8b99-79e4fed4a2ff
Public Version Date
November 09, 2021
Public Version Number
4
DI Record Publish Date
October 31, 2017
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 |