PURblue P1102-1212

GUDID 05051775000783

PURblue CMX, 1-2mm granules, 12cc

ORTHOGEM LTD

Synthetic bone graft

• Primary Device ID: 05051775000783
• NIH Device Record Key: 478813bc-3b59-442f-b3f7-e67a8a87756d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PURblue
• Version Model Number: P1102-1212
• Catalog Number: P1102-1212
• 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	05051775000783 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150064

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 [PURblue]

• 05051775000868: PURblue CMX, 1-2mm granules, 10cc
• 05051775000851: PURblue CMX, 1-2mm granules, 5cc
• 05051775000844: PURblue CMX, 1-4mm granules, 10cc
• 05051775000837: PURblue CMX, 1-4mm granules, 5cc
• 05051775000783: PURblue CMX, 1-2mm granules, 12cc
• 05051775000776: PURblue CMX, 1-2mm granules, 8cc
• 05051775000769: PURblue CMX, 1-4mm granules, 12cc
• 05051775000752: PURblue CMX, 1-4mm granules, 8cc
• 05051775000547: PURblue Block Large, 9*2*0.56cm, 10cc
• 05051775000530: PURblue Block Medium, 5*2*1cm, 10cc
• 05051775000523: PURblue Block Small, 5*2*0.5cm, 5cc
• 05051775000516: PURblue in bottle blister, 2-4mm granules, 30cc
• 05051775000509: PURblue in bottle blister, 2-4mm granules, 20cc
• 05051775000493: PURblue in bottle blister, 2-4mm granules, 15cc
• 05051775000486: PURblue in bottle blister, 2-4mm granules, 10cc
• 05051775000479: PURblue in bottle blister, 2-4mm granules, 5cc
• 05051775000462: PURblue in bottle blister, 1-2mm granules, 15cc
• 05051775000455: PURblue in bottle blister, 1-2mm granules, 10cc
• 05051775000448: PURblue in bottle blister, 1-2mm granules, 5cc
• 05051775000431: PURblue in bottle blister, 1-2mm granules, 2cc
• 05051775000424: PURblue in bottle blister, 0.5-0.85mm granules, 5cc
• 05051775000417: PURblue in bottle blister, 0.5-0.85mm granules, 2cc