1.5 mm Inion OTPS™ PCK-7001

GUDID 06438408005978

1.5 mm Pin Kit

Inion Oy

Orthopaedic bone pin, bioabsorbable

• Primary Device ID: 06438408005978
• NIH Device Record Key: 3e199858-b869-4fd9-ba01-33d286125b0f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 1.5 mm Inion OTPS™
• Version Model Number: 1
• Catalog Number: PCK-7001
• Company DUNS: 367994657
• Company Name: Inion Oy
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06438408005978 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031712

FDA Product Code

• HTY: PIN, FIXATION, SMOOTH

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-09
• Device Publish Date: 2023-09-29

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• 06438408006005: 1.5 x 30 mm pin
• 06438408005992: 1.5 x 20 mm pin
• 06438408005978: 1.5 mm Pin Kit