Duns Number:943156836
Device Description: Micro-Introducer Kit
Catalog Number
KIT-069-15
Brand Name
Micro-Introducer Kit
Version/Model Number
KIT-069-15
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 15, 2020
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"
Yes
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
OFL
Product Code Name
Percutaneous Sheath Introducer Kit
Public Device Record Key
5356db96-d8da-49bf-94fb-45fbaaa3fe75
Public Version Date
December 16, 2020
Public Version Number
4
DI Record Publish Date
March 21, 2017
Package DI Number
20841268107216
Quantity per Package
100
Contains DI Package
10841268107219
Package Discontinue Date
December 15, 2020
Package Status
Not in Commercial Distribution
Package Type
Shipper Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 29 |
2 | A medical device with a moderate to high risk that requires special controls. | 696 |