Duns Number:006261481
Device Description: BALLOON SPR4012W SPRINTER OTW 4.0X12MM
Catalog Number
-
Brand Name
Sprinter™
Version/Model Number
SPR4012W
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
P790017
Product Code
LOX
Product Code Name
Catheters, transluminal coronary angioplasty, percutaneous
Public Device Record Key
69132676-9de8-4c26-b998-1fce0f0c2343
Public Version Date
October 07, 2019
Public Version Number
4
DI Record Publish Date
January 14, 2018
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 |