Duns Number:943156836
Device Description: 4F x 60cm Micro-Introducer Kit
Catalog Number
INT0460
Brand Name
4F x 60cm Micro-Introducer Kit
Version/Model Number
CLI-131-60
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"
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
066a3e53-92db-4a5c-bdea-d044a152e209
Public Version Date
November 08, 2021
Public Version Number
1
DI Record Publish Date
October 29, 2021
Package DI Number
10841268109602
Quantity per Package
10
Contains DI Package
00841268109605
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shelf 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 |