STERIS - ICM-000-0621 STERIS Non-Telescopic ESU Pencil, - I.C. MEDICAL, INC.

Duns Number:616182895

Device Description: ICM-000-0621 STERIS Non-Telescopic ESU Pencil, Non-Stick Blade, 10 Foot Tube, 22 mm to 10 ICM-000-0621 STERIS Non-Telescopic ESU Pencil, Non-Stick Blade, 10 Foot Tube, 22 mm to 10 mm Connector & Holster, Non-Sterile, Bulk

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More Product Details

Catalog Number

SSEPEN09

Brand Name

STERIS

Version/Model Number

SSEPEN09

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"

Yes

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 Details

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Device Record Status

Public Device Record Key

eaa8da30-ad98-4bde-8102-dc67b174bd48

Public Version Date

October 27, 2021

Public Version Number

1

DI Record Publish Date

October 19, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"I.C. 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. 180