Lasso - Lasso Polypectomy Snare - DIVERSATEK HEALTHCARE, INC.

Duns Number:030650113

Device Description: Lasso Polypectomy Snare

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More Product Details

Catalog Number

-

Brand Name

Lasso

Version/Model Number

1180-15

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"

Yes

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

FGX

Product Code Name

Snare, Non-Electrical

Device Record Status

Public Device Record Key

3a237ac6-128c-4ec5-bcb1-d7288246cce6

Public Version Date

March 08, 2021

Public Version Number

1

DI Record Publish Date

February 26, 2021

Additional Identifiers

Package DI Number

10816734023058

Quantity per Package

10

Contains DI Package

00816734023051

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