OCTABONE

GUDID 08809490620840

CHIYEWON.LTD

Dental bone matrix implant, animal-derived
Primary Device ID08809490620840
NIH Device Record Key4de739f6-a283-4234-b14b-d1a6a180a292
Commercial Distribution StatusIn Commercial Distribution
Brand NameOCTABONE
Version Model Number25-0210
Company DUNS689846859
Company NameCHIYEWON.LTD
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 Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809490620840 [Primary]

FDA Product Code

NPMBone Grafting Material, Animal Source

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-04
Device Publish Date2018-01-22

On-Brand Devices [OCTABONE]

0880949062091825-1217
0880949062090105-1217
0880949062089510-1217
0880949062088820-1217
0880949062087120-0210
0880949062086410-0210
0880949062085705-0210
0880949062084025-0210

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.