Duns Number:023055619
Device Description: Titanium Probe 8-1/2" / 21.5 CM
Catalog Number
3003-800P
Brand Name
SCANLAN® Titanium Probes
Version/Model Number
3003-800P
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
GZX
Product Code Name
Instrument, Microsurgical
Public Device Record Key
e517a2ef-4320-476f-ac5f-2e6c626e3925
Public Version Date
February 13, 2020
Public Version Number
1
DI Record Publish Date
February 05, 2020
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 | 1949 |
2 | A medical device with a moderate to high risk that requires special controls. | 855 |