Comfortear Lacrisolve 180 Absorbable Punctum Plug - Canalicular plug - RIVERPOINT MEDICAL, LLC

Duns Number:964053560

Device Description: Canalicular plug

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More Product Details

Catalog Number

-

Brand Name

Comfortear Lacrisolve 180 Absorbable Punctum Plug

Version/Model Number

42702-175-03

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)

-

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

LZU

Product Code Name

Plug, Punctum

Device Record Status

Public Device Record Key

2559a390-968e-471a-991d-2fd563d2fede

Public Version Date

February 24, 2020

Public Version Number

1

DI Record Publish Date

February 14, 2020

Additional Identifiers

Package DI Number

20810020080807

Quantity per Package

10

Contains DI Package

00810020080803

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"RIVERPOINT MEDICAL, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 12
2 A medical device with a moderate to high risk that requires special controls. 1369
U Unclassified 8