MICTEC SUCTION TUBE - MICTEC SUCTION TUBE WITH BASKET, BIG CENTRAL - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: MICTEC SUCTION TUBE WITH BASKET, BIG CENTRAL OPENING CURVED

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More Product Details

Catalog Number

-

Brand Name

MICTEC SUCTION TUBE

Version/Model Number

20943-14

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 23, 2018

Issuing Agency

In HIBCC

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

-

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

K002877

Product Code Details

Product Code

HET

Product Code Name

Laparoscope, Gynecologic (And Accessories)

Device Record Status

Public Device Record Key

8334163a-abf2-42fd-a108-35ba495afb4d

Public Version Date

September 24, 2018

Public Version Number

7

DI Record Publish Date

September 30, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SONTEC INSTRUMENTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10108
2 A medical device with a moderate to high risk that requires special controls. 3414