Duns Number:692666613
Device Description: The MM51/YOH is for use as surgical microscope designed to magnify minute structuresin the The MM51/YOH is for use as surgical microscope designed to magnify minute structuresin the fields for surgery.
Catalog Number
-
Brand Name
Surgical Microscope MM51/YOH
Version/Model Number
MM51/YOH
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"
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For Single-Use
-
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
EPT
Product Code Name
Microscope, Surgical
Public Device Record Key
4847a82c-1e9f-4513-a9e7-0dea562ec27d
Public Version Date
August 21, 2019
Public Version Number
2
DI Record Publish Date
September 03, 2018
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |