OrthoPediatrics QuickPack Bone Void Filler OPQS1008

GUDID 00841132177587

QUICKPACK KIT 8cc

ORTHOPEDIATRICS CORP.

Bone matrix implant, synthetic

• Primary Device ID: 00841132177587
• NIH Device Record Key: c31c4103-7ee0-4b64-952e-0dd5241a29b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OrthoPediatrics QuickPack Bone Void Filler
• Version Model Number: OPQS1008
• Catalog Number: OPQS1008
• Company DUNS: 796416191
• Company Name: ORTHOPEDIATRICS CORP.
• 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: 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: +1(574)268-6379
• Email: jjaskula@orthopediatrics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841132177587 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093343

FDA Product Code

• MQV: FILLER, BONE VOID, CALCIUM COMPOUND

Sterilization

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

[00841132177587]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-19
• Device Publish Date: 2020-02-11

On-Brand Devices [OrthoPediatrics QuickPack Bone Void Filler]

• 00841132177617: DEMO QUICKPACK DELIVERING GUN
• 00841132177600: DEMO QUICKPACK DOSE
• 00841132177594: QUICKPACK KIT 16cc
• 00841132177587: QUICKPACK KIT 8cc
• 00841132177570: QUICKPACK KIT 5cc