STERIS - ICM-000-0649 STERIS ESU Shroud, Short Tip, 9 Foot - I.C. MEDICAL, INC.

Duns Number:616182895

Device Description: ICM-000-0649 STERIS ESU Shroud, Short Tip, 9 Foot Tube & 22 mm to 10 mm Connector, Non-Ste ICM-000-0649 STERIS ESU Shroud, Short Tip, 9 Foot Tube & 22 mm to 10 mm Connector, Non-Sterile, Bulk

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More Product Details

Catalog Number

SSESHR03

Brand Name

STERIS

Version/Model Number

SSESHR03

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"

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

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Device Record Status

Public Device Record Key

a74603cd-dd5b-48c0-b116-128372bb3fb9

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