Tubing, sterile, for UHl smoke evacuation - Promepla

Duns Number:401020409

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More Product Details

Catalog Number

ONG04299ST119

Brand Name

Tubing, sterile, for UHl smoke evacuation

Version/Model Number

WA95007A

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

FCZ

Product Code Name

Tube, Smoke Removal, Endoscopic

Device Record Status

Public Device Record Key

3dac8dd5-914a-4fc9-9ddc-36e625fdd4a0

Public Version Date

July 07, 2020

Public Version Number

6

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

03700512925095

Quantity per Package

20

Contains DI Package

03700512905097

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"PROMEPLA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 64
2 A medical device with a moderate to high risk that requires special controls. 152