MinerOss X Syringe BH0032

GUDID 00614950009077

MinerOss X Syringe Particle Size 0.25mm - 1.0mm 0.25cc

ACE SURGICAL SUPPLY CO., INC.

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

• Primary Device ID: 00614950009077
• NIH Device Record Key: 20063cfc-e6d6-4fac-8007-ad7e9b4539dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MinerOss X Syringe
• Version Model Number: BH0032
• Catalog Number: BH0032
• 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: 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

Customer Support Contacts

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

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00614950009077 [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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-07-19

On-Brand Devices [MinerOss X Syringe]

• 00614950009084: MinerOss X Syringe Particle Size 0.25mm - 1.0mm 0.5 cc
• 00614950009077: MinerOss X Syringe Particle Size 0.25mm - 1.0mm 0.25cc