ChitoZolve

GUDID 00821925044166

ChitoZolve Finished Good (8/pk)

Gyrus Acmi, Inc.

Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived Intranasal splint, non-bioabsorbable, animal-derived
Primary Device ID00821925044166
NIH Device Record Key58fff807-a5b8-483a-80a5-1240fa610b5f
Commercial Distribution StatusIn Commercial Distribution
Brand NameChitoZolve
Version Model NumberCNS155
Company DUNS007198742
Company NameGyrus Acmi, Inc.
Device Count8
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100821925044159 [Primary]
GS100821925044166 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LYASplint, Intranasal Septal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-11
Device Publish Date2020-12-03

Devices Manufactured by Gyrus Acmi, Inc.

00810008180983 - nCare2023-10-02 nCare, D, DRCT SDI, ELA, DICOM, RCRDG
00810008180990 - nCare2023-10-02 nCare,D ,2 DRCT SDI, DICOM, RCRDG
00810008180501 - nCare2023-09-25 nCare, Sgl,Direct SDI,DICOM,Rcrdg
00810008180921 - nCare2023-09-25 nCare, Dual,ELA x 2,DICOM,Rcrdg
00810008180952 - nCare2023-09-25 nCare, SNGL,DRCT SDI,DICOM
00810008180969 - nCare2023-09-25 nCare, SNGL, ELA, DICOM
00810008180976 - nCare2023-09-25 nCare, SNGL, ELA, DICOM, RCRDG
00821925036406 - USA Elite2023-07-26 ACMI USA Elite System and USA Series Knife Electrode 24 Fr (8mm)

Trademark Results [ChitoZolve]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CHITOZOLVE
CHITOZOLVE
88048174 5789572 Live/Registered
OLYMPUS CORPORATION
2018-07-23

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