Cidex - Cidex Activated Dialdehyde 4.7 Liter - ADVANCED STERILIZATION PRODUCTS SERVICES INC.

Duns Number:947451626

Device Description: Cidex Activated Dialdehyde 4.7 Liter

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More Product Details

Catalog Number

2266

Brand Name

Cidex

Version/Model Number

2266

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K060618,K060618

Product Code Details

Product Code

MED

Product Code Name

Sterilant, medical devices

Device Record Status

Public Device Record Key

69e1d42f-4e83-4237-9a85-f51e8eec5703

Public Version Date

March 19, 2021

Public Version Number

7

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

20705037044587

Quantity per Package

4

Contains DI Package

10705037044580

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"ADVANCED STERILIZATION PRODUCTS SERVICES INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 20
2 A medical device with a moderate to high risk that requires special controls. 159