I.CO.S® - The silicone base is part of the container with - NEWDEAL

Duns Number:536935331

Device Description: The silicone base is part of the container with reference 119985ND used in the transport a The silicone base is part of the container with reference 119985ND used in the transport and the sterilization of the associated instruments and non-sterile implants. It is composed of one base with two silicone bumpers to securely maintain the devices, one carpet with reference 119988ND and four wedges with reference 119909ND.The transport and sterilization containers are not intended to maintain sterility.

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More Product Details

Catalog Number

-

Brand Name

I.CO.S®

Version/Model Number

119986ND

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

-

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

FSM

Product Code Name

TRAY, SURGICAL, INSTRUMENT

Device Record Status

Public Device Record Key

8a919dd4-2f75-429f-8d38-4bf2ba17545a

Public Version Date

July 08, 2021

Public Version Number

5

DI Record Publish Date

May 26, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NEWDEAL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 388
2 A medical device with a moderate to high risk that requires special controls. 235