Profiniti AFP02

GUDID 00813954025339

Moldable Putty Bone Graft Matrix

COLLAGEN MATRIX, INC.

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Primary Device ID	00813954025339
NIH Device Record Key	4a0b67dd-5d5d-4dfb-b5e0-6a582dc1693e
Commercial Distribution Status	In Commercial Distribution
Brand Name	Profiniti
Version Model Number	AFP02
Catalog Number	AFP02
Company DUNS	176262442
Company Name	COLLAGEN MATRIX, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

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Operating and Storage Conditions

Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813954025339 [Primary]

FDA Product Code

MQV	Filler, Bone Void, Calcium Compound

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-02-28
Device Publish Date	2023-02-20

On-Brand Devices [Profiniti]

00813954025117	Moldable Graft
00813954025100	Moldable Graft
00813954025353	Moldable Putty Bone Graft Matrix
00813954025346	Moldable Putty Bone Graft Matrix
00813954025339	Moldable Putty Bone Graft Matrix

Trademark Results [Profiniti]

Mark Image Registration \| Serial	Company Trademark Application Date
PROFINITI 97522651 not registered Live/Pending	Coastal Biologics, LLC 2022-07-27