Duns Number:618214410
Device Description: Detachable Locking Swivel Scope Holder (3mm to 12.7mm diameter) for Martin's Arm Stand, he Detachable Locking Swivel Scope Holder (3mm to 12.7mm diameter) for Martin's Arm Stand, hex fitting with plastic Delrin holder
Catalog Number
115-306QC
Brand Name
Hayden Medical
Version/Model Number
115-306QC
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
FWZ
Product Code Name
Operating Room Accessories Table Tray
Public Device Record Key
0f329c1e-b71d-4ad8-9184-1b176f3c1445
Public Version Date
August 16, 2022
Public Version Number
1
DI Record Publish Date
August 08, 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 |