Duns Number:079720472
Device Description: D.A.S.H. Pre-Loaded With Acrobat 2 Wire Guide
Catalog Number
DASH-AWG2-25-450
Brand Name
DASH
Version/Model Number
G57298
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
K172665
Product Code
KNS
Product Code Name
Unit, electrosurgical, endoscopic (with or without accessories)
Public Device Record Key
3f1f40b7-93ff-433d-ae79-0fe2d8ac0a90
Public Version Date
February 05, 2021
Public Version Number
2
DI Record Publish Date
September 29, 2020
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 | 669 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8328 |
| 3 | A medical device with high risk that requires premarket approval | 370 |
| U | Unclassified | 242 |