TriPore

GUDID 05051775000721

Block size 2, 5*2*1cm

ORTHOGEM LTD

Synthetic bone graft

• Primary Device ID: 05051775000721
• NIH Device Record Key: 49f7d95f-c2b8-4b96-9c34-d2cd5dfc8076
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TriPore
• Version Model Number: 3107-0002
• Company DUNS: 220574912
• Company Name: ORTHOGEM LTD
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	05051775000721 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070132

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-24

On-Brand Devices [TriPore]

• 05051775000820: Granules in MPA, 1-4mm granules, 10cc
• 05051775000813: Granules in MPA, 1-4mm granules, 5cc
• 05051775000806: Granules in MPA, 1-2mm granules, 10cc
• 05051775000790: Granules in MPA, 1-2mm granules, 5cc
• 05051775000745: TriPore in MPA, 1-2mm granules, 12cc
• 05051775000738: TriPore in MPA, 1-2mm granules, 8cc
• 05051775000721: Block size 2, 5*2*1cm
• 05051775000714: Block size 1, 5*2*0.5cm, 5cc
• 05051775000707: Block size 3, 9*2*0.56cm, 10cc
• 05051775000691: TriPore HA in bottle blister, 2-4mm granules, 30cc
• 05051775000684: TriPore HA in bottle blister 2-4mm granules, 20cc
• 05051775000677: TriPore HA in bottle blister 2-4mm granules, 15cc
• 05051775000660: TriPore HA in bottle blister 2-4mm granules, 10cc
• 05051775000653: TriPore HA in bottle blister 2-4mm granules, 5cc
• 05051775000646: TriPore Ha in bottle blister 1-2mm granules, 15cc
• 05051775000639: TriPore HA in bottle blister 1-2mm granules, 10cc
• 05051775000622: TriPore HA in bottle blister 1-2mm granules, 5cc
• 05051775000615: TriPore HA in bottle blister 1-2mm granules, 2cc
• 05051775000608: TriPore HA in bottle blister 0.5-0.85mm granules, 5cc
• 05051775000592: TriPore HA in bottle blister 0.5-0.85mm granules, 2cc
• 05051775000400: TriPore HA in bottle blister, 1-2mm granules, 2cc
• 05051775000394: TriPore HA in bottle blister, 1-2mm granules, 1.5cc
• 05051775000387: TriPore HA in bottle blister, 1-2mm granules, 1cc
• 05051775000370: TriPore HA in bottle blister, 0.5-0.85mm granules, 2cc
• 05051775000363: TriPore HA in bottle blister 0.5-0.85mm granules, 1.5cc
• 05051775000356: TriPore HA in bottle blister, 0.5-0.85mm granules, 1cc
• 05051775000349: TriPore HA in bottle blister, 0.5-0.85mm granules, 0.5cc
• 05051775000332: TriPore HA in bottle blister, 0.25-0.5mm granules, 1.5cc
• 05051775000325: TriPore HA in bottle blister, 0.25-0.5mm granules, 1cc
• 05051775000318: TriPore HA in bottle blister, 0.25-0.5mm ganules, 0.5cc
• 05051775000288: TriPore in MPA, 1-4mm granules, 12cc
• 05051775000271: TriPore HA in MPA, 1-4mm granules, 8cc