Playbook 01-4200-0001

GUDID 00840194471954

Playbook Assembly

ORTHOPEDIATRICS CORP.

Medical image management system

• Primary Device ID: 00840194471954
• NIH Device Record Key: 9717d99a-4847-4ce7-93e6-b1b78474aaaf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Playbook
• Version Model Number: 01-4200-0001
• Catalog Number: 01-4200-0001
• Company DUNS: 796416191
• Company Name: ORTHOPEDIATRICS CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• 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	00840194471954 [Primary]

FDA Product Code

• OUG: Medical device data system

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-26
• Device Publish Date: 2024-07-18

On-Brand Devices [Playbook]

• 00840194471954: Playbook Assembly
• 00840194493765: Assembled Playbook Unit
• 00840194493871: Playbook Software