MinerOss® X BH0031

GUDID 00614950007905

MinerOss®X SYRINGE PARTICLE SIZE 250-1000µ 1.0CC

ACE SURGICAL SUPPLY CO., INC.

Dental bone matrix implant, animal-derived Dental bone matrix implant, animal-derived Dental bone matrix implant, animal-derived Dental bone matrix implant, animal-derived Dental bone matrix implant, animal-derived Dental bone matrix implant, animal-derived Dental bone matrix implant, animal-derived Dental bone matrix implant, animal-derived Dental bone matrix implant, animal-derived Dental bone matrix implant, animal-derived Dental bone matrix implant, animal-derived Dental bone matrix implant, animal-derived Dental bone matrix implant, animal-derived Dental bone matrix implant, animal-derived Dental bone matrix implant, animal-derived Dental bone matrix implant, animal-derived Dental bone matrix implant, animal-derived

• Primary Device ID: 00614950007905
• NIH Device Record Key: a3e02817-3444-4563-9595-a8e2e51d6900
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MinerOss® X
• Version Model Number: MINX-SYR1.0
• Catalog Number: BH0031
• Company DUNS: 042763706
• Company Name: ACE SURGICAL SUPPLY CO., INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: +1(508)588-3100
• Email: ritaknight@acesurgical.com
• Phone: +1(508)588-3100
• Email: ritaknight@acesurgical.com
• Phone: +1(508)588-3100
• Email: regulatoryandquality@acesurgical.com
• Phone: +1(508)588-3100
• Email: regulatoryandquality@acesurgical.com
• Phone: +1(508)588-3100
• Email: regulatoryandquality@acesurgical.com
• Phone: +1(508)588-3100
• Email: regulatoryandquality@acesurgical.com
• Phone: +1(508)588-3100
• Email: regulatoryandquality@acesurgical.com
• Phone: +1(508)588-3100
• Email: regulatoryandquality@acesurgical.com
• Phone: +1(508)588-3100
• Email: regulatoryandquality@acesurgical.com
• Phone: +1(508)588-3100
• Email: regulatoryandquality@acesurgical.com
• Phone: +1(508)588-3100
• Email: regulatoryandquality@acesurgical.com
• Phone: +1(508)588-3100
• Email: regulatoryandquality@acesurgical.com
• Phone: +1(508)588-3100
• Email: regulatoryandquality@acesurgical.com
• Phone: +1(508)588-3100
• Email: regulatoryandquality@acesurgical.com
• Phone: +1(508)588-3100
• Email: regulatoryandquality@acesurgical.com
• Phone: +1(508)588-3100
• Email: regulatoryandquality@acesurgical.com
• Phone: +1(508)588-3100
• Email: regulatoryandquality@acesurgical.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00614950007905 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170541

FDA Product Code

• NPM: BONE GRAFTING MATERIAL, ANIMAL SOURCE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-02-06

On-Brand Devices [MinerOss® X]

• 00614950008896: MinerOss X COLLAGEN SIZE 6X7X8MM
• 00614950008889: MinerOss® X CANCELLOUS PARTICLE SIZE 250-1000µ 0.25G/.5CC
• 00614950007974: MinerOss®X CORTICAL PARTICLE SIZE 500-1000µ 2.0G/3.2CC
• 00614950007967: MinerOss®X CORTICAL PARTICLE SIZE 500-1000µ 1.0G/1.6CC
• 00614950007950: MinerOss®X CANCELLOUS PARTICLE SIZE 250-1000µ 0.5G/1.0CC
• 00614950007943: MinerOss®X COLLAGEN SIZE 10X11X12MM
• 00614950007936: MinerOss® X COLLAGEN SIZE 8X9X9MM
• 00614950007929: MinerOss®X SYRINGE PARTICLE SIZE 250-1000µ 0.5CC
• 00614950007912: MinerOss®X SYRINGE PARTICLE SIZE 250-1000µ .25CC
• 00614950007905: MinerOss®X SYRINGE PARTICLE SIZE 250-1000µ 1.0CC
• 00614950007899: MinerOss X COLLAGEN SIZE 6X7X8MM
• 00614950007882: MinerOss® X CANCELLOUS PARTICLE SIZE 250-1000µ 2.0G/4.0CC
• 00614950007875: MinerOss® X CANCELLOUS PARTICLE SIZE 250-1000µ 1.0G/2.0CC
• 00614950007868: MinerOss® X CANCELLOUS PARTICLE SIZE 250-1000µ 0.25G/.5CC
• 00614950007851: MinerOss® X CORTICAL PARTICLE SIZE 500-1000µ 0.5G/.8CC