Duns Number:600325755
Catalog Number
-
Brand Name
XVS Headset IPD-68 LCD Display
Version/Model Number
AHMD681WLD
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
K190929,K190929
Product Code
OLO
Product Code Name
Orthopedic Stereotaxic Instrument
Public Device Record Key
1d2205d4-7d5d-419f-afb2-1a4aa59a9b14
Public Version Date
August 14, 2020
Public Version Number
1
DI Record Publish Date
August 06, 2020
Package DI Number
17290113780580
Quantity per Package
1
Contains DI Package
07290113780583
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipping Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 46 |