Trackable Suction - Tube 12-L-30 - Synaptive Medical Inc

Duns Number:203061833

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More Product Details

Catalog Number

-

Brand Name

Trackable Suction - Tube 12-L-30

Version/Model Number

SYN-0653

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

-

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

GCX

Product Code Name

Apparatus, Suction, Operating-Room, Wall Vacuum Powered

Device Record Status

Public Device Record Key

af39768a-f38e-4199-9e20-1fae048d27c6

Public Version Date

April 03, 2018

Public Version Number

3

DI Record Publish Date

February 28, 2017

Additional Identifiers

Package DI Number

10670082000211

Quantity per Package

3

Contains DI Package

00670082000214

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"SYNAPTIVE MEDICAL INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 36