MEDIVISIION - ARTHROSCOPEIntended use of MediVision Arthroscope - MEDIVISION, INC.

Duns Number:942192550

Device Description: ARTHROSCOPEIntended use of MediVision Arthroscope is for orthopedic use in the knee, shoul ARTHROSCOPEIntended use of MediVision Arthroscope is for orthopedic use in the knee, shoulder, wrist (carpal ligament release), temporal-mandibular joint, ankle, elbow, and plantar fascia release.SINUSCOPEIntended use of MediVision Sinuscope is to allow direct visualization (through the Sinuscope or the video monitor) of the nasal cavity.

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More Product Details

Catalog Number

MVA2702

Brand Name

MEDIVISIION

Version/Model Number

MVA2702

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

EOB

Product Code Name

Nasopharyngoscope (Flexible Or Rigid)

Device Record Status

Public Device Record Key

5b1f2a06-0e76-4c91-95fd-3ac66a153a95

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 14, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDIVISION, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 25