EZ CONNECT2™ Dual Cylinder Adapter, psi - Visual-ICE Cryoablation System Accessory - BOSTON SCIENTIFIC CORPORATION

Duns Number:831630103

Device Description: Visual-ICE Cryoablation System Accessory

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More Product Details

Catalog Number

FRPCH4004

Brand Name

EZ CONNECT2™ Dual Cylinder Adapter, psi

Version/Model Number

FPRCH4004

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

-

Product Code Details

Product Code

GEH

Product Code Name

Unit, Cryosurgical, Accessories

Device Record Status

Public Device Record Key

c0609ffa-9c86-40c9-904e-44ed123bca4d

Public Version Date

April 08, 2022

Public Version Number

8

DI Record Publish Date

August 15, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BOSTON SCIENTIFIC CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 536
2 A medical device with a moderate to high risk that requires special controls. 8659
3 A medical device with high risk that requires premarket approval 1821
U Unclassified 35