OsteoPore Plus DBM Putty 5.0cc Syringe

GUDID 00849777013482

ONE (1) PACKAGE - CONTAINING 5.0 CC

Xtant Medical Holdings, Inc.

Bone matrix implant, human-derived
Primary Device ID00849777013482
NIH Device Record Key6a1f0a38-b1d6-4f70-a1a9-723f699f6e52
Commercial Distribution StatusIn Commercial Distribution
Brand NameOsteoPore Plus DBM Putty 5.0cc Syringe
Version Model NumberSC-5205-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
GS100849777013482 [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 5.0cc Syringe]

00849777013451ONE (1) PACKAGE - CONTAINING 5.0CC
00849777013482ONE (1) PACKAGE - CONTAINING 5.0 CC

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