InQu IQSP-MX-125

GUDID 00865179000035

5x5cm Matrix

ISTO TECHNOLOGIES INC

Synthetic bone graft

• Primary Device ID: 00865179000035
• NIH Device Record Key: 3a10fd00-baee-4b2c-8930-4aaaef5d289e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InQu
• Version Model Number: IN007
• Catalog Number: IQSP-MX-125
• Company DUNS: 035854152
• Company Name: ISTO TECHNOLOGIES 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: 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00865179000035 [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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-09-01

On-Brand Devices [InQu]

• 00865179000073: 1.25cc Paste Mix Plus
• 00865179000066: 2.5cc Paste Mix Plus
• 00865179000059: 5cc Paste Mix Plus
• 00865179000042: 10cc Paste Mix Plus
• 00865179000035: 5x5cm Matrix
• 00865179000028: 5x10cm Matrix
• 00865179000011: 10cc Granules
• 00865179000004: 30cc Granules