Tubing, with filter, sterile, for insuflation - Promepla

Duns Number:401020409

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More Product Details

Catalog Number

ONG04199ST119

Brand Name

Tubing, with filter, sterile, for insuflation

Version/Model Number

WA95005A

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

NKC

Product Code Name

Tubing/Tubing With Filter, Insufflation, Laparoscopic

Device Record Status

Public Device Record Key

f98403ba-1eba-495b-901f-0a41df03c1e2

Public Version Date

July 07, 2020

Public Version Number

5

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

14042761072639

Quantity per Package

20

Contains DI Package

03700512905080

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