STERIS - ICM-000-0662 STERIS Non-Telescopic ESU Pencil, - I.C. MEDICAL, INC.

Duns Number:616182895

Device Description: ICM-000-0662 STERIS Non-Telescopic ESU Pencil, Stainless Steel ENT Needle, 10 Foot Tube, U ICM-000-0662 STERIS Non-Telescopic ESU Pencil, Stainless Steel ENT Needle, 10 Foot Tube, Universal Connector & Holster, Sterile

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More Product Details

Catalog Number

SSEPEN15

Brand Name

STERIS

Version/Model Number

SSEPEN15

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

51164cb5-5280-4b2b-922c-ccf49aea38d7

Public Version Date

May 19, 2022

Public Version Number

1

DI Record Publish Date

May 11, 2022

Additional Identifiers

Package DI Number

00817688023739

Quantity per Package

20

Contains DI Package

00817688023722

Package Discontinue Date

-

Package Status

In Commercial Distribution

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