FrostAway™ FROSTAWAYPEN-CA

GUDID 05407008487003

H & O Equipments SA

General cryosurgical system, cryogen gas, mechanical
Primary Device ID05407008487003
NIH Device Record Key60d7f170-c405-440a-9c41-3f43b85bf465
Commercial Distribution StatusIn Commercial Distribution
Brand NameFrostAway™
Version Model NumberFrostAway Pen cartridges
Catalog NumberFROSTAWAYPEN-CA
Company DUNS370212933
Company NameH & O Equipments SA
Device Count6
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-888-248-2838
Emailcryoprobe@ho-equipments.com
Phone1-888-248-2838
Emailcryoprobe@ho-equipments.com
Phone1-888-248-2838
Emailcryoprobe@ho-equipments.com
Phone1-888-248-2838
Emailcryoprobe@ho-equipments.com
Phone1-888-248-2838
Emailcryoprobe@ho-equipments.com
Phone1-888-248-2838
Emailcryoprobe@ho-equipments.com
Phone1-888-248-2838
Emailcryoprobe@ho-equipments.com
Phone1-888-248-2838
Emailcryoprobe@ho-equipments.com
Phone1-888-248-2838
Emailcryoprobe@ho-equipments.com
Phone1-888-248-2838
Emailcryoprobe@ho-equipments.com
Phone1-888-248-2838
Emailcryoprobe@ho-equipments.com
Phone1-888-248-2838
Emailcryoprobe@ho-equipments.com
Phone1-888-248-2838
Emailcryoprobe@ho-equipments.com
Phone1-888-248-2838
Emailcryoprobe@ho-equipments.com
Phone1-888-248-2838
Emailcryoprobe@ho-equipments.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105407008487003 [Unit of Use]
GS115407008487017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEHUnit, Cryosurgical, Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-26
Device Publish Date2025-05-18

On-Brand Devices [FrostAway™]

05407008487003FrostAway Pen cartridges
15407008487000FrostAway Pen

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