Distraction Pin, 12MM pouch

GUDID 10818614022601

Sharp Distraction Pin, 12MM pouch

Maruho Medical, Inc.

Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use Intraoperative orthopaedic bone pin/screw, single-use

• Primary Device ID: 10818614022601
• NIH Device Record Key: 428ad89b-273e-433e-ad7f-e7cef12106ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Distraction Pin, 12MM pouch
• Version Model Number: SS-0088S
• 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: 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 Dimensions

• Length: 12 Millimeter
• Length: 12 Millimeter
• Length: 12 Millimeter
• Length: 12 Millimeter
• Length: 12 Millimeter
• Length: 12 Millimeter
• Length: 12 Millimeter
• Length: 12 Millimeter
• Length: 12 Millimeter
• Length: 12 Millimeter
• Length: 12 Millimeter
• Length: 12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818614022604 [Primary]
GS1	10818614022601 [Package]; Contains: 00818614022604; 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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2023-06-02
• Device Publish Date: 2022-12-19

Devices Manufactured by Maruho Medical, Inc.

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• 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: 2023-06-02Sharp Distraction Pin, 12MM pouch
• 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
• 00818614021355 - Apollo Medial with needles: 2022-09-09 Apollo Medial with needles
• 00818614022550 - Distraction Screw, 12MM Pouch: 2022-09-09 Synergy Distraction Screw, 12MM Pouch