Amsco V-PRO - The Amsco V-PRO 1 Low Temperature Sterilization - Steris Mexico, S. de R.L. de C.V.

Duns Number:813116209

Device Description: The Amsco V-PRO 1 Low Temperature Sterilization System is intended for use in the terminal The Amsco V-PRO 1 Low Temperature Sterilization System is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) metal and nonmetal medical devices used in Healthcare Facilities.

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More Product Details

Catalog Number

VP1

Brand Name

Amsco V-PRO

Version/Model Number

1

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

-

Product Code Details

Product Code

MLR

Product Code Name

Sterilizer, chemical

Device Record Status

Public Device Record Key

8ac3cabe-8c81-42a3-8e90-3a77886c882a

Public Version Date

October 21, 2020

Public Version Number

5

DI Record Publish Date

September 14, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STERIS MEXICO, S. DE R.L. DE C.V." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 548