NuOss XC Sinus 5093002

GUDID 00813954028002

Self-Expanding Composite

COLLAGEN MATRIX, INC.

Dental bone matrix implant, animal-derived
Primary Device ID00813954028002
NIH Device Record Key642cfe5d-9d58-40f8-b093-2e648c33b30f
Commercial Distribution StatusIn Commercial Distribution
Brand NameNuOss XC Sinus
Version Model Number5093002
Catalog Number5093002
Company DUNS176262442
Company NameCOLLAGEN MATRIX, 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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-624-5926
EmailInfo@acesouthern.com
Phone800-624-5926
EmailInfo@acesouthern.com
Phone800-624-5926
EmailInfo@acesouthern.com
Phone800-624-5926
EmailInfo@acesouthern.com
Phone800-624-5926
EmailInfo@acesouthern.com
Phone800-624-5926
EmailInfo@acesouthern.com
Phone800-624-5926
EmailInfo@acesouthern.com
Phone800-624-5926
EmailInfo@acesouthern.com
Phone800-624-5926
EmailInfo@acesouthern.com
Phone800-624-5926
EmailInfo@acesouthern.com
Phone800-624-5926
EmailInfo@acesouthern.com
Phone800-624-5926
EmailInfo@acesouthern.com
Phone800-624-5926
EmailInfo@acesouthern.com

Device Dimensions

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Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100614950007349 [Previous]
GS100813954028002 [Primary]

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 Date2026-01-15
Device Publish Date2026-01-07

On-Brand Devices [NuOss XC Sinus]

00813954028002Self-Expanding Composite
00813954027999Self-Expanding Composite

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