MICRO FLOW™ - PUNCTAL OCCLUDER BULK SMALL 0.4MM-0.55MM - Beaver-Visitec International, Inc.

Duns Number:001406024

Device Description: PUNCTAL OCCLUDER BULK SMALL 0.4MM-0.55MM

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More Product Details

Catalog Number

A20-401BN

Brand Name

MICRO FLOW™

Version/Model Number

A20-401BN

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

LZU

Product Code Name

Plug, Punctum

Device Record Status

Public Device Record Key

2fc8666e-ffab-4bc8-988e-c4fefe1e12dd

Public Version Date

February 10, 2022

Public Version Number

1

DI Record Publish Date

February 02, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BEAVER-VISITEC INTERNATIONAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 441
2 A medical device with a moderate to high risk that requires special controls. 35
U Unclassified 34