Duns Number:654386890
Device Description: Delicate design and exquisite workmanship.Table liftable and rotatable.Convenient use for Delicate design and exquisite workmanship.Table liftable and rotatable.Convenient use for both adult and children.Rotary tray for auto refractometer and other optical devices.Electric lifting system for chair and arm.
Catalog Number
-
Brand Name
Ophthalmic unit
Version/Model Number
TCS-880
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"
Yes
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
HRJ
Product Code Name
Table, Instrument, Powered, Ophthalmic
Public Device Record Key
fbcd8dd3-ea50-48f0-a302-0a220d86b145
Public Version Date
August 09, 2021
Public Version Number
1
DI Record Publish Date
July 30, 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 | 15 |