Duns Number:101835833
Device Description: Peel-Away Introducer Set, 6F
Catalog Number
AP06045P
Brand Name
Adelante Peel-Away Introducer Set
Version/Model Number
AP06045P
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
K073100,K073100
Product Code
DYB
Product Code Name
INTRODUCER, CATHETER
Public Device Record Key
84d748e6-5209-46a7-91df-3ff09fe2c370
Public Version Date
June 07, 2019
Public Version Number
4
DI Record Publish Date
November 15, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 592 |
3 | A medical device with high risk that requires premarket approval | 16 |