Osseofit™ Porous Tissue Matrix 50604-08

GUDID 00812337021531

DSM BIOMEDICAL, INC.

Composite bone graft
Primary Device ID00812337021531
NIH Device Record Key414c6896-a78e-476d-8798-128776982dcc
Commercial Distribution Discontinuation2019-09-30
Commercial Distribution StatusNot in Commercial Distribution
Brand NameOsseofit™ Porous Tissue Matrix
Version Model Number50604-08
Catalog Number50604-08
Company DUNS131107757
Company NameDSM BIOMEDICAL, 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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone484-713-2100
Emailclinreg.extonpa@dsm.com
Phone484-713-2100
Emailclinreg.extonpa@dsm.com
Phone484-713-2100
Emailclinreg.extonpa@dsm.com
Phone484-713-2100
Emailclinreg.extonpa@dsm.com
Phone484-713-2100
Emailclinreg.extonpa@dsm.com
Phone484-713-2100
Emailclinreg.extonpa@dsm.com
Phone484-713-2100
Emailclinreg.extonpa@dsm.com
Phone484-713-2100
Emailclinreg.extonpa@dsm.com
Phone484-713-2100
Emailclinreg.extonpa@dsm.com
Phone484-713-2100
Emailclinreg.extonpa@dsm.com
Phone484-713-2100
Emailclinreg.extonpa@dsm.com
Phone484-713-2100
Emailclinreg.extonpa@dsm.com
Phone484-713-2100
Emailclinreg.extonpa@dsm.com
Phone484-713-2100
Emailclinreg.extonpa@dsm.com
Phone484-713-2100
Emailclinreg.extonpa@dsm.com
Phone484-713-2100
Emailclinreg.extonpa@dsm.com
Phone484-713-2100
Emailclinreg.extonpa@dsm.com
Phone484-713-2100
Emailclinreg.extonpa@dsm.com
Phone484-713-2100
Emailclinreg.extonpa@dsm.com
Phone484-713-2100
Emailclinreg.extonpa@dsm.com
Phone484-713-2100
Emailclinreg.extonpa@dsm.com
Phone484-713-2100
Emailclinreg.extonpa@dsm.com
Phone484-713-2100
Emailclinreg.extonpa@dsm.com
Phone484-713-2100
Emailclinreg.extonpa@dsm.com
Phone484-713-2100
Emailclinreg.extonpa@dsm.com
Phone484-713-2100
Emailclinreg.extonpa@dsm.com
Phone484-713-2100
Emailclinreg.extonpa@dsm.com
Phone484-713-2100
Emailclinreg.extonpa@dsm.com
Phone484-713-2100
Emailclinreg.extonpa@dsm.com
Phone484-713-2100
Emailclinreg.extonpa@dsm.com
Phone484-713-2100
Emailclinreg.extonpa@dsm.com
Phone484-713-2100
Emailclinreg.extonpa@dsm.com
Phone484-713-2100
Emailclinreg.extonpa@dsm.com

Device Dimensions

Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter
Circumference8 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100812337021531 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Number5
Public Version Date2019-10-01
Device Publish Date2015-09-01

On-Brand Devices [Osseofit™ Porous Tissue Matrix]

0081233702156250604-15
0081233702155550604-12
0081233702154850604-10
0081233702153150604-08
0081233702152450604-06
0081233702151750604-04

Trademark Results [Osseofit]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OSSEOFIT
OSSEOFIT
97924878 not registered Live/Pending
Zimmer, Inc.
2023-05-08

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