N/A - Ablation Cable from SMARTABLATE System to CELSIUS - STRYKER SUSTAINABILITY SOLUTIONS, INC.

Duns Number:020198912

Device Description: Ablation Cable from SMARTABLATE System to CELSIUS Catheter (TC/THR), 10'

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More Product Details

Catalog Number

D130302

Brand Name

N/A

Version/Model Number

N/A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

-

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

IKD

Product Code Name

CABLE, ELECTRODE

Device Record Status

Public Device Record Key

cca7ab3b-b861-4b61-a9ad-78051a22ef75

Public Version Date

October 12, 2022

Public Version Number

1

DI Record Publish Date

October 04, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STRYKER SUSTAINABILITY SOLUTIONS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 304
2 A medical device with a moderate to high risk that requires special controls. 1702
U Unclassified 12