AR Supply Hose, 4.5m, bar - Cryoablation System Accessory - GALIL MEDICAL INC.

Duns Number:809529469

Device Description: Cryoablation System Accessory

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More Product Details

Catalog Number

FPRCH6118

Brand Name

AR Supply Hose, 4.5m, bar

Version/Model Number

FPRCH6118

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 15, 2017

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

64693744-8e8c-49d2-a0db-66fab508975d

Public Version Date

April 08, 2022

Public Version Number

7

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

-

"GALIL MEDICAL INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 43