Duns Number:202738675
Device Description: DIROS ADAPTER (4MM BANANA PIN TO OWL GD-PAD CORDED) FOR COSMAN, NEUROTHERM, RADIONICS, STR DIROS ADAPTER (4MM BANANA PIN TO OWL GD-PAD CORDED) FOR COSMAN, NEUROTHERM, RADIONICS, STRYKER, & SMITH & NEPHEW RF DEVICES
Catalog Number
C473-004-S
Brand Name
OWL
Version/Model Number
C473-004-S
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
IKD
Product Code Name
Cable, Electrode
Public Device Record Key
c0aa9846-be7d-497a-88f6-fca6c79fd2c2
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 01, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 396 |