EquivaBone ®

GUDID 00889024205529

Etex Corporation

Synthetic bone graft
Primary Device ID00889024205529
NIH Device Record Keyaee24237-4bd3-454e-8b03-c8900d081d33
Commercial Distribution StatusIn Commercial Distribution
Brand NameEquivaBone ®
Version Model Number76-6027
Company DUNS622221141
Company NameEtex Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Producttrue
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone877-383-9276
Emailsales@etexcorp.com

Device Dimensions

Total Volume2.5 Milliliter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at 15-25 Degrees Celcius Keep Dry Keep Away From Sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS100889024205529 [Primary]

FDA Product Code

MQVFiller, Bone Void, Calcium Compound

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-12-17
Device Publish Date2015-10-24

On-Brand Devices [EquivaBone ® ]

0088902420555076-6041
0088902420554376-6022
0088902420553676-6021
0088902420552976-6027

Trademark Results [EquivaBone]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EQUIVABONE
EQUIVABONE
77365875 3609804 Live/Registered
Etex Corporation
2008-01-07

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