itto

GUDID 10818614022434

Itto S+L shuttle and loop for use with itto CSP 20 in size 1 UHMWPE

Maruho Medical, Inc.

Suturing needle, single-use

• Primary Device ID: 10818614022434
• NIH Device Record Key: 41dcca6e-b4b3-4142-810c-bec983e8937f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: itto
• Version Model Number: 52-10120
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818614022437 [Primary]
GS1	10818614022434 [Package]; Contains: 00818614022437; Package: box [8 Units]; In Commercial Distribution

FDA Product Code

• NBH: Accessories, Arthroscopic

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: 2021-10-04
• Device Publish Date: 2021-09-24

On-Brand Devices [itto ]

• 10818614022434: Itto S+L shuttle and loop for use with itto CSP 20 in size 1 UHMWPE
• 10818614022427: Itto S+L shuttle and loop for use with itto CSP 2 in size 1 UHMWPE