Duns Number:006261481
Device Description: DEB ADM04015008P 04.00 L150 UL0800 US
Catalog Number
-
Brand Name
IN.PACT™ Admiral™
Version/Model Number
ADM04015008P
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P140010,P140010,P140010,P140010,P140010,P140010,P140010,P140010
Product Code
ONU
Product Code Name
Drug-Eluting Peripheral Transluminal Angioplasty Catheter
Public Device Record Key
698531d5-e3a2-4cf6-b778-75fd3db4e20a
Public Version Date
May 27, 2021
Public Version Number
6
DI Record Publish Date
September 03, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |