Cerene Cryotherapy Device

GUDID 00850008595035

CHANNEL MEDSYSTEMS, INC.

Hand-held cryosurgical system Hand-held cryosurgical system Hand-held cryosurgical system Hand-held cryosurgical system Hand-held cryosurgical system Hand-held cryosurgical system Hand-held cryosurgical system Hand-held cryosurgical system Hand-held cryosurgical system Hand-held cryosurgical system Hand-held cryosurgical system Hand-held cryosurgical system Hand-held cryosurgical system Hand-held cryosurgical system
Primary Device ID00850008595035
NIH Device Record Key17af5448-366c-4141-a382-3d959ce6bd5b
Commercial Distribution StatusIn Commercial Distribution
Brand NameCerene Cryotherapy Device
Version Model NumberFGS-7000
Company DUNS963415513
Company NameCHANNEL MEDSYSTEMS, INC.
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone510-338-9301
Emailsupport@channelmedsystems.com
Phone510-338-9301
Emailsupport@channelmedsystems.com
Phone510-338-9301
Emailsupport@channelmedsystems.com
Phone510-338-9301
Emailsupport@channelmedsystems.com
Phone510-338-9301
Emailsupport@channelmedsystems.com
Phone510-338-9301
Emailsupport@channelmedsystems.com
Phone510-338-9301
Emailsupport@channelmedsystems.com
Phone510-338-9301
Emailsupport@channelmedsystems.com
Phone510-338-9301
Emailsupport@channelmedsystems.com
Phone510-338-9301
Emailsupport@channelmedsystems.com
Phone510-338-9301
Emailsupport@channelmedsystems.com
Phone510-338-9301
Emailsupport@channelmedsystems.com
Phone510-338-9301
Emailsupport@channelmedsystems.com
Phone510-338-9301
Emailsupport@channelmedsystems.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850008595035 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNBDevice, Thermal Ablation, Endometrial

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-31
Device Publish Date2020-08-21

Devices Manufactured by CHANNEL MEDSYSTEMS, INC.

20850008595022 - Exhaust Collection Bag2020-08-31 Single exhaust collection bag in pouch
00850008595035 - Cerene Cryotherapy Device2020-08-31
00850008595035 - Cerene Cryotherapy Device2020-08-31

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