Duns Number:607903382
Device Description: Stamey Dorsal Vein Apical Retractor. Stainless steel throughout. Handle flange provides se Stamey Dorsal Vein Apical Retractor. Stainless steel throughout. Handle flange provides secure control and cephaled retraction. Retractor blades provide a wide space on both sides of the dorsal vein complex for placing a controlling suture.
Catalog Number
U530
Brand Name
Greenwald Surgical Company, Inc.
Version/Model Number
51200-00
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
-
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
FGN
Product Code Name
Retractor, Non-Self-Retaining
Public Device Record Key
130f579a-a389-41fd-8601-bf13804f2c68
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 31, 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 | 186 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 220 |