N/A - CHANNEL CONN. TUBE, WHITE - PENTAX OF AMERICA, INC.

Duns Number:083211284

Device Description: CHANNEL CONN. TUBE, WHITE

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More Product Details

Catalog Number

-

Brand Name

N/A

Version/Model Number

841401

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

K152189

Product Code Details

Product Code

FEB

Product Code Name

Accessories, Cleaning, For Endoscope

Device Record Status

Public Device Record Key

f2c6af7a-3fe3-44ce-9d62-68c9cb80310c

Public Version Date

June 22, 2021

Public Version Number

5

DI Record Publish Date

March 05, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PENTAX OF AMERICA, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 247
2 A medical device with a moderate to high risk that requires special controls. 425