Duns Number:204326292
Catalog Number
-
Brand Name
7D Surgical Registration Frame
Version/Model Number
11-0066
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
Yes
Prescription Use (Rx)
-
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
d633ab2c-11f4-4b73-bdc5-e020c1024ef8
Public Version Date
April 15, 2022
Public Version Number
2
DI Record Publish Date
July 27, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 85 |