BARON SUCTION TUBE - BARON SUCTION TUBE - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: BARON SUCTION TUBE

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More Product Details

Catalog Number

-

Brand Name

BARON SUCTION TUBE

Version/Model Number

412-710E

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

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

HTY

Product Code Name

Pin, Fixation, Smooth

Device Record Status

Public Device Record Key

030aa64b-6266-40cf-b62d-f0d96bcc9237

Public Version Date

September 24, 2018

Public Version Number

5

DI Record Publish Date

September 05, 2017

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