Distraction Pin , 12MM Pouch 909-12-K

GUDID 20818614022509

KateMar Distraction Pin , 12MM Pouch

Maruho Medical, Inc.

Intraoperative bone pin/screw, sterile

• Primary Device ID: 20818614022509
• NIH Device Record Key: 70df0177-4fcd-4c6a-9465-a8462a15ef31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Distraction Pin , 12MM Pouch
• Version Model Number: 909-12
• Catalog Number: 909-12-K
• Company DUNS: 117630237
• Company Name: Maruho Medical, Inc.
• 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: 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818614022505 [Primary]
GS1	20818614022509 [Package]; Contains: 00818614022505; Package: Box [10 Units]; In Commercial Distribution

FDA Product Code

• LYQ: Accessories, Fixation, Spinal Intervertebral Body

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: 2022-05-16
• Device Publish Date: 2022-05-06

Devices Manufactured by Maruho Medical, Inc.

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• 10818614022595 - Disposable Punch, 6.5 mm: 2024-06-05 Disposable Punch, 6.5 mm Pouch
• 00818614022635 - ABS Med Distraction Pin: 2023-09-06 ABS Med Distraction Pin , 12MM Pouch
• 10818614022649 - ABS Med Distraction Pin: 2023-09-06 ABS Med Distraction Pin, 14MM Patient (Inner)
• 10818614021406 - Distraction Screw: 2023-06-02 Distraction Screw, 12MM Patient (Inner)
• 10818614021413 - Distraction Screw: 2023-06-02 Distraction Screw, 14MM Patient (Inner)
• 10818614022601 - Distraction Pin, 12MM pouch: 2023-06-02 Sharp Distraction Pin, 12MM pouch
• 10818614022618 - Distraction Pin, 14MM pouch: 2023-06-02 Sharp Distraction Pin, 14MM pouch