PLENA Graft 0.5cc Syringe PMCS05

GUDID 00813954027005

Anorganic Bone Mineral in Syringe

COLLAGEN MATRIX, INC.

Dental bone matrix implant, animal-derived
Primary Device ID00813954027005
NIH Device Record Keyfc021163-1d3b-4cd4-bf9d-893ad4e5e503
Commercial Distribution StatusIn Commercial Distribution
Brand NamePLENA Graft 0.5cc Syringe
Version Model NumberPMCS05
Catalog NumberPMCS05
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

Phone+390499124300
Emailinfo@sweden-martina.com
Phone+390499124300
Emailinfo@sweden-martina.com
Phone+390499124300
Emailinfo@sweden-martina.com
Phone+390499124300
Emailinfo@sweden-martina.com
Phone+390499124300
Emailinfo@sweden-martina.com
Phone+390499124300
Emailinfo@sweden-martina.com
Phone+390499124300
Emailinfo@sweden-martina.com
Phone+390499124300
Emailinfo@sweden-martina.com
Phone+390499124300
Emailinfo@sweden-martina.com
Phone+390499124300
Emailinfo@sweden-martina.com
Phone+390499124300
Emailinfo@sweden-martina.com
Phone+390499124300
Emailinfo@sweden-martina.com
Phone+390499124300
Emailinfo@sweden-martina.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
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 Celsius and 86 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Celsius and 86 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Celsius and 86 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Celsius and 86 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Celsius and 86 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Celsius and 86 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Celsius and 86 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Celsius and 86 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Celsius and 86 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Celsius and 86 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Celsius and 86 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Celsius and 86 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100813954027005 [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 Date2025-08-11
Device Publish Date2025-08-01

On-Brand Devices [PLENA Graft 0.5cc Syringe]

00813954027111Anorganic Bone Mineral in Syringe
00813954027005Anorganic Bone Mineral in Syringe

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