InterOss®

GUDID 00852072007148

SIGMAGRAFT, INC.

Dental bone matrix implant, animal-derived
Primary Device ID00852072007148
NIH Device Record Key2619c1e8-4de4-42f9-b205-4c01af0af210
Commercial Distribution StatusIn Commercial Distribution
Brand NameInterOss®
Version Model NumberIOLGS150
Company DUNS078893672
Company NameSIGMAGRAFT, 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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(714)525-0114
Emailquality.sigmagraft@sigmagraft.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100852072007148 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2018-10-03
Device Publish Date2016-09-20

On-Brand Devices [InterOss®]

00852072007018IOSG025

Trademark Results [InterOss]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INTEROSS
INTEROSS
85789028 4456430 Live/Registered
SigmaGraft, Inc.
2012-11-28

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