OSTEOPAL® 66031896

GUDID 04260102130326

Osteopal® V is an acrylic cement for use in vertebroplasty and kyphoplasty. It is formed from powder and liquid by exothermic polymerization

Heraeus Medical GmbH

Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial
Primary Device ID04260102130326
NIH Device Record Keyce596653-402c-44ef-a9ff-7bf008216078
Commercial Distribution StatusIn Commercial Distribution
Brand NameOSTEOPAL®
Version Model NumberV
Catalog Number66031896
Company DUNS333623937
Company NameHeraeus Medical GmbH
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104260102130326 [Package]
Contains: 04260102130494
Package: Carton [20 Units]
In Commercial Distribution
GS104260102130494 [Primary]
GS104260102132283 [Package]
Contains: 04260102130494
Package: Pallet [400 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LODBone Cement

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-18
Device Publish Date2020-08-10

On-Brand Devices [OSTEOPAL®]

04260102132603OSTEOPAL® plus is a radiopaque, low-viscosity bone cement, based on polymethyl methacrylate wit
04260102130326Osteopal® V is an acrylic cement for use in vertebroplasty and kyphoplasty. It is formed from p

Trademark Results [OSTEOPAL]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OSTEOPAL
OSTEOPAL
87410764 not registered Live/Pending
Heraeus Medical GmbH
2017-04-13
OSTEOPAL
OSTEOPAL
74470554 2031356 Live/Registered
HERAEUS MEDICAL GMBH
1993-12-17
OSTEOPAL
OSTEOPAL
74442278 not registered Dead/Abandoned
MALLINCKRODT, INC.
1993-09-29
OSTEOPAL
OSTEOPAL
73633752 1444843 Dead/Cancelled
E. MERCK
1986-12-04

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