CryoOne 5115

GUDID 04053815079163

Zimmer MedizinSysteme GmbH

Cold-air therapy unit
Primary Device ID04053815079163
NIH Device Record Key4e84ad66-b805-4828-bafb-dc7d0872c856
Commercial Distribution StatusIn Commercial Distribution
Brand NameCryoOne
Version Model Number5115
Catalog Number5115
Company DUNS316111251
Company NameZimmer MedizinSysteme GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
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

Phone(800) 327-3576
Emailinfo@zimmerusa.com
Phone(800) 327-3576
Emailinfo@zimmerusa.com
Phone(800) 327-3576
Emailinfo@zimmerusa.com
Phone(800) 327-3576
Emailinfo@zimmerusa.com
Phone(800) 327-3576
Emailinfo@zimmerusa.com
Phone(800) 327-3576
Emailinfo@zimmerusa.com
Phone(800) 327-3576
Emailinfo@zimmerusa.com
Phone(800) 327-3576
Emailinfo@zimmerusa.com
Phone(800) 327-3576
Emailinfo@zimmerusa.com
Phone(800) 327-3576
Emailinfo@zimmerusa.com
Phone(800) 327-3576
Emailinfo@zimmerusa.com
Phone(800) 327-3576
Emailinfo@zimmerusa.com
Phone(800) 327-3576
Emailinfo@zimmerusa.com
Phone(800) 327-3576
Emailinfo@zimmerusa.com
Phone(800) 327-3576
Emailinfo@zimmerusa.com
Phone(800) 327-3576
Emailinfo@zimmerusa.com
Phone(800) 327-3576
Emailinfo@zimmerusa.com
Phone(800) 327-3576
Emailinfo@zimmerusa.com
Phone(800) 327-3576
Emailinfo@zimmerusa.com
Phone(800) 327-3576
Emailinfo@zimmerusa.com
Phone(800) 327-3576
Emailinfo@zimmerusa.com
Phone(800) 327-3576
Emailinfo@zimmerusa.com
Phone(800) 327-3576
Emailinfo@zimmerusa.com
Phone(800) 327-3576
Emailinfo@zimmerusa.com
Phone(800) 327-3576
Emailinfo@zimmerusa.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104053815079163 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-13
Device Publish Date2020-07-05

Devices Manufactured by Zimmer MedizinSysteme GmbH

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04053815086369 - ZShape2024-07-29
04053815087229 - Cryo 72024-06-04
04053815076711 - MFG-052023-10-24
04053815081296 - ThermoTK2023-06-13
04053815083344 - clTrac2023-06-13
04053815078562 - emField2022-05-19
04053815080848 - Cryo 72022-03-09

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