Gas Supply Line (5 m) - Cryoablation System Accessory - GALIL MEDICAL INC.

Duns Number:809529469

Device Description: Cryoablation System Accessory

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More Product Details

Catalog Number

FPRCH6131

Brand Name

Gas Supply Line (5 m)

Version/Model Number

FPRCH6131

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

5e4cbc4a-f272-482c-a5f8-145161cf72ce

Public Version Date

April 08, 2022

Public Version Number

5

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