TRIHA+ T824415

GUDID 03760177040793

TEKNIMED

Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial
Primary Device ID03760177040793
NIH Device Record Keyf80b31dd-a2a0-4cc1-9d31-3f98ca3c175f
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRIHA+
Version Model NumberGranules 3x3x3 30cc
Catalog NumberT824415
Company DUNS764746723
Company NameTEKNIMED
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 Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Device Size Text, specify0
Pore Size220 Micrometer
Weight18.7 Gram
Device Size Text, specify0
Pore Size220 Micrometer
Weight18.7 Gram
Device Size Text, specify0
Pore Size220 Micrometer
Weight18.7 Gram
Device Size Text, specify0
Pore Size220 Micrometer
Weight18.7 Gram
Device Size Text, specify0
Pore Size220 Micrometer
Weight18.7 Gram
Device Size Text, specify0
Pore Size220 Micrometer
Weight18.7 Gram
Device Size Text, specify0
Pore Size220 Micrometer
Weight18.7 Gram
Device Size Text, specify0
Pore Size220 Micrometer
Weight18.7 Gram
Device Size Text, specify0
Pore Size220 Micrometer
Weight18.7 Gram

Device Identifiers

Device Issuing AgencyDevice ID
GS103760177040793 [Primary]

FDA Product Code

MQVFiller, Bone Void, Calcium Compound

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-10-26
Device Publish Date2015-10-16

On-Brand Devices [TRIHA+]

03760177043817Granules 6x3x2 20cc
03760177043800Granules 6x3x2 10cc
03760177043794Granules 6x3x2 5cc
03760177041509Chips 2-5mm 20cc
03760177041493Chips 2-5mm 10cc
03760177041486Chips 1-2mm 20cc
03760177041479Chips 1-2mm 10cc
03760177040816Stick 5x5x20 10 units
03760177040809Stick 5x5x20 5 units
03760177040793Granules 3x3x3 30cc
03760177040762Granules 3x3x3 10cc
03760177040755Granules 3x3x3 5cc

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.