C2 CryoBalloon FG-1031

GUDID 00854924006316

180 Standard Catheter 30-mm

C2 THERAPEUTICS, INC.

Gastrointestinal/biliary dilation balloon catheter
Primary Device ID00854924006316
NIH Device Record Keydb771aca-39a9-4884-911c-5fabc240b832
Commercial Distribution StatusIn Commercial Distribution
Brand NameC2 CryoBalloon
Version Model NumberFG-1031
Catalog NumberFG-1031
Company DUNS929139249
Company NameC2 THERAPEUTICS, 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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100854924006316 [Primary]

FDA Product Code

GEHUnit, Cryosurgical, Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-04-09
Device Publish Date2018-03-08

On-Brand Devices [C2 CryoBalloon]

00854924006316180 Standard Catheter 30-mm
0085492400630990 Standard Catheter 30-mm
00854924006286Focal Standard Catheter 30-mm
00854924006279180 Pear Catheter
0085492400626290 Pear Catheter
00854924006248Pear Catheter Focal
00854924006187Foot Pedal
00854924006170Controller

Trademark Results [C2 CryoBalloon]

Mark Image

Registration | Serial
Company
Trademark
Application Date
C2 CRYOBALLOON
C2 CRYOBALLOON
86899206 5177795 Live/Registered
PENTAX OF AMERICA, INC.
2016-02-05

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