Catalog Number

M00542980

Brand Name

SpyGlass™ Discover

Version/Model Number

M00542980

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

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

GBZ

Product Code Name

CATHETER, CHOLANGIOGRAPHY

Public Device Record Key

8e9b5b13-b28c-4d9e-b59a-b0013c51d286

Public Version Date

June 17, 2021

Public Version Number

1

DI Record Publish Date

June 09, 2021

Package DI Number

00191506005238

Quantity per Package

5

Contains DI Package

00191506005221

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-