MICROVAC® - ULTRA MALLEABLE SURGICAL SUCTION - PMT CORPORATION

Duns Number:039576871

Device Description: ULTRA MALLEABLE SURGICAL SUCTION

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More Product Details

Catalog Number

3101-13

Brand Name

MICROVAC®

Version/Model Number

3101-13

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

JOL

Product Code Name

Catheter And Tip, Suction

Device Record Status

Public Device Record Key

85603900-780b-4932-95e8-467e3fdf55f0

Public Version Date

August 21, 2019

Public Version Number

4

DI Record Publish Date

August 01, 2016

Additional Identifiers

Package DI Number

00650551038023

Quantity per Package

12

Contains DI Package

00650551038016

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"PMT CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 673
2 A medical device with a moderate to high risk that requires special controls. 8273
U Unclassified 1188