Duns Number:943156836
Device Description: Micro-Introducer Kit
Catalog Number
SR-4F21G4D-MP
Brand Name
Micro-Introducer Kit
Version/Model Number
KIT-075-00
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 07, 2019
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
b09fcee5-3aba-4da4-8aac-e97f9968e85b
Public Version Date
June 10, 2019
Public Version Number
4
DI Record Publish Date
March 21, 2017
Package DI Number
20841268106929
Quantity per Package
100
Contains DI Package
10841268106922
Package Discontinue Date
June 07, 2019
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 |