Duns Number:109903521
Device Description: FIRSTPASS NEEDLE AND SUTURE CAPTURE, 5 PER BOX
Catalog Number
22-4036
Brand Name
FIRSTPASS
Version/Model Number
22-4036
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
Yes
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
NBH
Product Code Name
ACCESSORIES,ARTHROSCOPIC
Public Device Record Key
c3d23d9e-c679-4abe-8849-b025aa2a4a3c
Public Version Date
December 04, 2020
Public Version Number
4
DI Record Publish Date
November 13, 2017
Package DI Number
20817470000188
Quantity per Package
5
Contains DI Package
00817470000184
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10651 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
| 3 | A medical device with high risk that requires premarket approval | 351 |