OsteoCrete® Bone Void Filler 44-100-00-BSI

GUDID B4474410000BSI1

OsteoCrete® is an injectable, moldable, and biocompatible Bone Void Filler. OsteoCrete® Bone Void Filler Packet contains powder (Magnesium based compound) and a mixing solution (Buffered saline). It is a sterile, single use device, packaged with mixing and administration tools.

BONE SOLUTIONS, INC.

Bone matrix implant, synthetic Bone matrix implant, synthetic

• Primary Device ID: B4474410000BSI1
• NIH Device Record Key: b04e93c7-7802-470a-a709-a9929a066c65
• Commercial Distribution Discontinuation: 2020-02-18
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: OsteoCrete® Bone Void Filler
• Version Model Number: 10cc
• Catalog Number: 44-100-00-BSI
• Company DUNS: 003506272
• Company Name: BONE SOLUTIONS, 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: false
• Device Kit: true
• 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: 8178098850
• Email: customerservice@bonesolutions.net
• Phone: 8178098850
• Email: customerservice@bonesolutions.net

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 89 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B4474410000BSI1 [Primary]

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: 2020-02-20
• Device Publish Date: 2017-08-04

On-Brand Devices [OsteoCrete® Bone Void Filler]

• B4474415000BSI2: OsteoCrete® is an injectable, moldable, and biocompatible Bone Void Filler. OsteoCrete® Bone V
• B4474410000BSI1: OsteoCrete® is an injectable, moldable, and biocompatible Bone Void Filler. OsteoCrete® Bone V
• B4474405000BSI0: OsteoCrete® is an injectable, moldable, and biocompatible Bone Void Filler. OsteoCrete® Bone V
• B4474415000STR0: OsteoCrete® is an injectable, moldable, and biocompatible Bone Void Filler. OsteoCrete® Bone V
• B4474415000BSI0: OsteoCrete® is an injectable, moldable, and biocompatible Bone Void Filler. OsteoCrete® Bone V
• B4474410000STR0: OsteoCrete® is an injectable, moldable, and biocompatible Bone Void Filler. OsteoCrete® Bone V
• B4474410000BSI0: OsteoCrete® is an injectable, moldable, and biocompatible Bone Void Filler. OsteoCrete® Bone V
• B4474405000STR0: OsteoCrete® is an injectable, moldable, and biocompatible Bone Void Filler. OsteoCrete® Bone V