Influx Plus Crunch 10.0cc - Syringe

GUDID 00849777011938

ONE (1) PACKAGE - CONTAINING 10.0cc

Xtant Medical Holdings, Inc.

Bone matrix implant, human-derived
Primary Device ID00849777011938
NIH Device Record Keyc7826aa9-aec8-48cd-b00b-5aa57f850064
Commercial Distribution StatusIn Commercial Distribution
Brand NameInflux Plus Crunch 10.0cc - Syringe
Version Model NumberIFLX-CR-10
Company DUNS081224143
Company NameXtant Medical Holdings, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Producttrue
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
Phone+1(888)886-9354
EmailCS@xtantmedical.com
Phone+1(888)886-9354
EmailCS@xtantmedical.com
Phone+1(888)886-9354
EmailCS@xtantmedical.com
Phone+1(888)886-9354
EmailCS@xtantmedical.com
Phone+1(888)886-9354
EmailCS@xtantmedical.com
Phone+1(888)886-9354
EmailCS@xtantmedical.com
Phone+1(888)886-9354
EmailCS@xtantmedical.com
Phone+1(888)886-9354
EmailCS@xtantmedical.com
Phone+1(888)886-9354
EmailCS@xtantmedical.com
Phone+1(888)886-9354
EmailCS@xtantmedical.com
Phone+1(888)886-9354
EmailCS@xtantmedical.com
Phone+1(888)886-9354
EmailCS@xtantmedical.com
Phone+1(888)886-9354
EmailCS@xtantmedical.com
Phone+1(888)886-9354
EmailCS@xtantmedical.com
Phone+1(888)886-9354
EmailCS@xtantmedical.com
Phone+1(888)886-9354
EmailCS@xtantmedical.com
Phone+1(888)886-9354
EmailCS@xtantmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100849777011938 [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 Date2021-09-02
Device Publish Date2021-08-25

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