IRIS Arthroscope

GUDID 08800147702643

HD Arthroscope 4.0 mm autoclavable 0

SOLENDOS Inc.

Rigid optical arthroscope, reusable

• Primary Device ID: 08800147702643
• NIH Device Record Key: 823a9a1a-e4b7-4599-a93c-76cacf05a489
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IRIS Arthroscope
• Version Model Number: TA240-100
• Company DUNS: 688020606
• Company Name: SOLENDOS Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +082269566541
• Email: ksc@solendos.com
• Phone: +082269566541
• Email: ksc@solendos.com
• Phone: +082269566541
• Email: ksc@solendos.com
• Phone: +082269566541
• Email: ksc@solendos.com
• Phone: +082269566541
• Email: ksc@solendos.com
• Phone: +082269566541
• Email: ksc@solendos.com
• Phone: +082269566541
• Email: ksc@solendos.com
• Phone: +082269566541
• Email: ksc@solendos.com
• Phone: +082269566541
• Email: ksc@solendos.com
• Phone: +082269566541
• Email: ksc@solendos.com
• Phone: +082269566541
• Email: ksc@solendos.com
• Phone: +082269566541
• Email: ksc@solendos.com
• Phone: +082269566541
• Email: ksc@solendos.com
• Phone: +082269566541
• Email: ksc@solendos.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800147702643 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080560

FDA Product Code

• HRX: Arthroscope

Sterilization

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

[08800147702643]

Moist Heat or Steam Sterilization

[08800147702643]

Moist Heat or Steam Sterilization

[08800147702643]

Moist Heat or Steam Sterilization

[08800147702643]

Moist Heat or Steam Sterilization

[08800147702643]

Moist Heat or Steam Sterilization

[08800147702643]

Moist Heat or Steam Sterilization

[08800147702643]

Moist Heat or Steam Sterilization

[08800147702643]

Moist Heat or Steam Sterilization

[08800147702643]

Moist Heat or Steam Sterilization

[08800147702643]

Moist Heat or Steam Sterilization

[08800147702643]

Moist Heat or Steam Sterilization

[08800147702643]

Moist Heat or Steam Sterilization

[08800147702643]

Moist Heat or Steam Sterilization

[08800147702643]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-15
• Device Publish Date: 2025-01-07

On-Brand Devices [IRIS Arthroscope]

• 08800147702841: Arthroscope 1.9 mm autoclavable 30
• 08800147702834: Arthroscope 1.9 mm autoclavable 0
• 08800147702827: Arthroscope 2.7 mm autoclavable 30
• 08800147702810: Arthroscope 2.7 mm autoclavable 0
• 08800147702681: HD3 Arthroscope 4.0 mm autoclavable 0
• 08800147702674: HD Arthroscope 4.0 mm autoclavable 30
• 08800147702667: HD3 Arthroscope 4.0 mm autoclavable 30
• 08800147702650: HD3 Arthroscope 4.0 mm autoclavable 70
• 08800147702643: HD Arthroscope 4.0 mm autoclavable 0
• 08800147702636: HD Arthroscope 4.0 mm autoclavable 70