ProSpace™ DBM Moldable Putty (Jar)

GUDID 00849777004725

2.5cc

BACTERIN INTERNATIONAL, INC.

Bone matrix implant, human-derived

• Primary Device ID: 00849777004725
• NIH Device Record Key: 491afb78-184d-421a-976d-3891ed4d0f71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProSpace™ DBM Moldable Putty (Jar)
• Version Model Number: ME914
• Company DUNS: 829387302
• Company Name: BACTERIN INTERNATIONAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: true
• Device Kit: false
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: true
• 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	00849777004725 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130498

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: 2016-10-18

On-Brand Devices [ProSpace™ DBM Moldable Putty (Jar)]

• 00849777004749: 10.0cc
• 00849777004732: 5.0cc
• 00849777004725: 2.5cc