Catalog Number

C010014

Brand Name

ENDOSCOPIC SEAL

Version/Model Number

C010014

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

ODC

Product Code Name

Endoscope Channel Accessory

Public Device Record Key

f3e3a179-da7c-4ea1-9b93-3613f5ebfb80

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 22, 2016

Package DI Number

M648C0100141

Quantity per Package

10

Contains DI Package

M648C0100140

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BAG