LiNA OperåScope™ Recording Module - Lina Medical ApS

Duns Number:305088619

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

OP‐RM‐1

Brand Name

LiNA OperåScope™ Recording Module

Version/Model Number

OP‐RM‐1

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

HIH

Product Code Name

Hysteroscope (And Accessories)

Device Record Status

Public Device Record Key

8c5490fe-0b22-42c3-b4c5-2a13a6798ec0

Public Version Date

June 07, 2019

Public Version Number

3

DI Record Publish Date

February 21, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LINA MEDICAL APS" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 19
2 A medical device with a moderate to high risk that requires special controls. 44