Duns Number:968623467
Device Description: Valved Peelable PTFE Introducer
Catalog Number
1003975-011
Brand Name
OptiSeal™
Version/Model Number
1003975-011
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
-
Product Code
DYB
Product Code Name
Introducer, Catheter
Public Device Record Key
83616eac-bc21-4b59-8860-b2947c252f98
Public Version Date
June 07, 2019
Public Version Number
2
DI Record Publish Date
September 24, 2018
Package DI Number
10821329601450
Quantity per Package
5
Contains DI Package
00821329601453
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 275 |
| 3 | A medical device with high risk that requires premarket approval | 68 |