Lasso - Lasso Polypectomy Snare - DIVERSATEK HEALTHCARE, INC.

Duns Number:030650113

Device Description: Lasso Polypectomy Snare

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More Product Details

Catalog Number

1180-10

Brand Name

Lasso

Version/Model Number

1180-10

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)

Yes

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

FDI

Product Code Name

Snare, Flexible

Device Record Status

Public Device Record Key

05ded554-a658-40cd-aac4-06a321727575

Public Version Date

March 22, 2019

Public Version Number

3

DI Record Publish Date

November 16, 2018

Additional Identifiers

Package DI Number

10816734021603

Quantity per Package

10

Contains DI Package

00816734021606

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case

"DIVERSATEK HEALTHCARE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 109
2 A medical device with a moderate to high risk that requires special controls. 207