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Amsco V-PRO

FDA UDI

Class II (US FDA UDI)

by Steris Mexico, S. de R.L. de C.V.

Identity

Trade Name
Amsco V-PRO FDA UDI
Generic Name
Hydrogen peroxide gas sterilizer FDA UDI
Device Name
The Amsco V-PRO 1 Plus 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. FDA UDI
Model / Reference
1 Plus FDA UDI
Description
The Amsco V-PRO 1 Plus 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. FDA UDI

Identifiers

Catalog Number
VP2 FDA UDI
Primary DI / UDI-DI
00724995151980 FDA UDI
510(k) Number
K083097 FDA UDI
K102330 FDA UDI
K102394 FDA UDI
K111810 FDA UDI
K112813 FDA UDI
K120632 FDA UDI
K131120 FDA UDI
K160433 FDA UDI
K162413 FDA UDI
K172319 FDA UDI
K190103 FDA UDI
FDA Product Code
MLR FDA UDI
GMDN Term
Hydrogen peroxide gas sterilizer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.6860 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Amsco V-PRO by Steris Mexico, S. de R.L. de C.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K083097 also covers:

K102330 also covers:

K102394 also covers:

K111810 also covers:

K112813 also covers:

K120632 also covers:

K131120 also covers:

K160433 also covers:

K162413 also covers:

K172319 also covers:

K190103 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Steris Mexico, S. de R.L. de C.V.

Sources (1)

  • FDA UDI 89174658-218e-4a1d-9ab8-0a1f39c34eac 37 fields · synced May 31, 2026