itto CSP

GUDID 00818614022475

Continuous Suture Passer

Maruho Medical, Inc.

Arthroscopic suturing unit Arthroscopic suturing unit Arthroscopic suturing unit Arthroscopic suturing unit Arthroscopic suturing unit Arthroscopic suturing unit Arthroscopic suturing unit Arthroscopic suturing unit Arthroscopic suturing unit Arthroscopic suturing unit Arthroscopic suturing unit Arthroscopic suturing unit Arthroscopic suturing unit Arthroscopic suturing unit Arthroscopic suturing unit Arthroscopic suturing unit

• Primary Device ID: 00818614022475
• NIH Device Record Key: 12a82b16-3316-4e21-b22d-3281840f0aa9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: itto CSP
• Version Model Number: 51-10001
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	00818614022475 [Primary]

FDA Product Code

• NBH: Accessories, Arthroscopic

Sterilization

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

[00818614022475]

Moist Heat or Steam Sterilization

[00818614022475]

Moist Heat or Steam Sterilization

[00818614022475]

Moist Heat or Steam Sterilization

[00818614022475]

Moist Heat or Steam Sterilization

[00818614022475]

Moist Heat or Steam Sterilization

[00818614022475]

Moist Heat or Steam Sterilization

[00818614022475]

Moist Heat or Steam Sterilization

[00818614022475]

Moist Heat or Steam Sterilization

[00818614022475]

Moist Heat or Steam Sterilization

[00818614022475]

Moist Heat or Steam Sterilization

[00818614022475]

Moist Heat or Steam Sterilization

[00818614022475]

Moist Heat or Steam Sterilization

[00818614022475]

Moist Heat or Steam Sterilization

[00818614022475]

Moist Heat or Steam Sterilization

[00818614022475]

Moist Heat or Steam Sterilization

[00818614022475]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-04
• Device Publish Date: 2021-09-24

Devices Manufactured by Maruho Medical, Inc.

• 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
• 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