Duns Number:181714804
Catalog Number
INS-0362
Brand Name
Always-On Tip Tracked Forceps, 1.8mm OD Oval Cup
Version/Model Number
INS-0362
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
K122106,K122106
Product Code
JAK
Product Code Name
System, X-Ray, Tomography, Computed
Public Device Record Key
c4fdbaba-5eb5-46a5-a1bf-492fcf437dc9
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 31, 2016
Package DI Number
10815686020559
Quantity per Package
5
Contains DI Package
00815686020552
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 31 |