Catalog Number

-

Brand Name

WATER RESISTANT CAP

Version/Model Number

MD-252

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K926514

Product Code

FDF

Product Code Name

Colonoscope and accessories, flexible/rigid

Public Device Record Key

405b6685-e19d-44c1-9ae3-86f5b00cd411

Public Version Date

December 15, 2021

Public Version Number

8

DI Record Publish Date

September 21, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-