LiNA OperaScope Angled Lasso - Lina Medical ApS

Duns Number:305088619

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More Product Details

Catalog Number

-

Brand Name

LiNA OperaScope Angled Lasso

Version/Model Number

OP-LAS16A-3

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

Yes

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

GAE

Product Code Name

Snare, Surgical

Device Record Status

Public Device Record Key

8aca2716-8570-4100-9089-4f9e2b4b5aa1

Public Version Date

November 11, 2020

Public Version Number

1

DI Record Publish Date

November 03, 2020

Additional Identifiers

Package DI Number

05708265012572

Quantity per Package

3

Contains DI Package

05708265012565

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box

"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