Visitec® - TAPERED HYDRODELINEATOR [BLUMENTHAL] .50 X 22MM - Beaver-Visitec International, Inc.

Duns Number:001406024

Device Description: TAPERED HYDRODELINEATOR [BLUMENTHAL] .50 X 22MM (25G X 7/8IN) (45 DEGREES)

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More Product Details

Catalog Number

585789

Brand Name

Visitec®

Version/Model Number

585789

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

HMX

Product Code Name

Cannula, Ophthalmic

Device Record Status

Public Device Record Key

0777b757-f1b8-4cde-b9b4-830ff345c789

Public Version Date

February 03, 2022

Public Version Number

1

DI Record Publish Date

January 26, 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