Duns Number:181714804
Catalog Number
INS-5910
Brand Name
SPiN Access Catheter, 90 Degrees For Use With Olympus 190 Scopes
Version/Model Number
INS-5910
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
K170023,K170023
Product Code
JAK
Product Code Name
System, X-Ray, Tomography, Computed
Public Device Record Key
cfa4da5a-5972-4adb-9c8f-81fd5a96b9f0
Public Version Date
March 28, 2022
Public Version Number
3
DI Record Publish Date
February 17, 2021
Package DI Number
10815686021273
Quantity per Package
5
Contains DI Package
00815686021276
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 |