Duns Number:079641356
Device Description: Vascular Dilator Malleable 2mm, 5 1/2"
Catalog Number
55-7005-H
Brand Name
Symmetry Garrett
Version/Model Number
55-7005-H
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
January 01, 9999
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
-
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
DWP
Product Code Name
Dilator, Vessel, Surgical
Public Device Record Key
ca0c4152-2c47-45fa-9729-7d33e9036236
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
June 08, 2016
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 | 7981 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3309 |