PuraXen+

GUDID 00852072007575

PuraXen+ Anorganic Cancellous Particulate (0.25-1.00mm) - 1.0g

SIGMAGRAFT, INC.

Dental bone matrix implant, animal-derived
Primary Device ID00852072007575
NIH Device Record Key6937c349-bb5c-49f3-8643-9b09797afea6
Commercial Distribution StatusIn Commercial Distribution
Brand NamePuraXen+
Version Model NumberXEN-250-100
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100852072007575 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-09
Device Publish Date2023-03-01

On-Brand Devices [PuraXen+]

00852072007650Puraxen+ Anorganic Cancellous Particulate (1.0-2.0mm) - 0.5cc syringe
00852072007643PuraXen+ Anorganic Cancellous Particulate (0.25 - 1.00mm) - 1.0cc syringe
00852072007636PuraXen+ Anorganic Cancellous Particulate (0.25-1.0mm) - 0.5cc syringe
00852072007629PuraXen+ Anorganic Cancellous Particulate (0.25-1.0mm) - 0.25cc syringe
00852072007612PuraXen+ Anorganic Cancellous Particulate (1.0-2.0mm) - 2.0g
00852072007605PuraXen+ Anorganic Cancellous Particulate (1.0-2.0mm) - 1.0g
00852072007599PuraXen+ Anorganic Cancellous Particulate (1.0-2.0mm) - 0.5g
00852072007582PuraXen+ Anorganic Cancellous Particulate (0.25-1.00mm) - 2.0g
00852072007575PuraXen+ Anorganic Cancellous Particulate (0.25-1.00mm) - 1.0g
00852072007568PuraXen+ Anorganic Cancellous Particulate (0.25-1.00mm) - 0.5g
00852072007209PuraXen+ Anorganic Cancellous Particulate (0.25-1.0mm) - 0.25g

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