Duns Number:483016148
Device Description: PERLA TL NAV. CORTICAL TAP Ø5.5 (Ø5.5 SCREW)
Catalog Number
NAV-IN 34 55-N
Brand Name
PERLA TL Cortical NAV-Instruments
Version/Model Number
NAV-IN 34 55-N
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
OLO
Product Code Name
Orthopedic Stereotaxic Instrument
Public Device Record Key
b714b9a6-8cc3-44c0-8b74-20c3e54c79d9
Public Version Date
April 06, 2021
Public Version Number
1
DI Record Publish Date
March 29, 2021
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 | 974 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5209 |