OsteoPore Plus DBM Putty 2.5cc Syringe

GUDID 00849777013475

ONE (1) PACKAGE - CONTAINING 2.5CC

Xtant Medical Holdings, Inc.

Bone matrix implant, human-derived
Primary Device ID00849777013475
NIH Device Record Key88927576-6966-477a-ac69-2d5b585cb13b
Commercial Distribution StatusIn Commercial Distribution
Brand NameOsteoPore Plus DBM Putty 2.5cc Syringe
Version Model NumberSC-5202-DBM
Company DUNS081224143
Company NameXtant Medical Holdings, 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 Producttrue
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100849777013475 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-02-27
Device Publish Date2025-02-19

On-Brand Devices [OsteoPore Plus DBM Putty 2.5cc Syringe]

00849777013444ONE (1) PACKAGE - CONTAINING 2.5CC
00849777013475ONE (1) PACKAGE - CONTAINING 2.5CC

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