Duns Number:618214410
Device Description: St. Mark's Deep Pelvic Fiber-Optic Retractor, hollow handle, 7" x 2-1/2" angled 15 degrees St. Mark's Deep Pelvic Fiber-Optic Retractor, hollow handle, 7" x 2-1/2" angled 15 degrees with lip (universal connection)
Catalog Number
240-586L
Brand Name
Hayden Medical
Version/Model Number
240-586L
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
GAD
Product Code Name
RETRACTOR
Public Device Record Key
56c62896-19bb-4900-8aff-0fd4f4cc5cd0
Public Version Date
August 08, 2022
Public Version Number
1
DI Record Publish Date
July 29, 2022
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 | 2893 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 195 |