MST/Packard A1 .7mm 12° Bend Phaco Tip, Reverse Bevel - MICROSURGICAL TECHNOLOGY, INC.

Duns Number:097824130

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More Product Details

Catalog Number

PT-33030-G

Brand Name

MST/Packard A1 .7mm 12° Bend Phaco Tip, Reverse Bevel

Version/Model Number

PT-33030-G

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K943672

Product Code Details

Product Code

HQC

Product Code Name

Unit, Phacofragmentation

Device Record Status

Public Device Record Key

092d912c-128c-431a-87e0-2c8af24427ba

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MICROSURGICAL TECHNOLOGY, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 327
2 A medical device with a moderate to high risk that requires special controls. 535