SuperBall-RC 12 degrees Down

GUDID 00850000630048

ARCURO MEDICAL LTD

Polyester suture, non-bioabsorbable, multifilament

• Primary Device ID: 00850000630048
• NIH Device Record Key: e7edad2f-8f3c-40b1-a08c-47e551c87112
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SuperBall-RC 12 degrees Down
• Version Model Number: A
• Company DUNS: 600664454
• Company Name: ARCURO MEDICAL LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850000630048 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K244015

FDA Product Code

• GAT: Suture, Nonabsorbable, Synthetic, Polyethylene

Sterilization

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

[00850000630048]

Ethylene Oxide

[00850000630048]

Ethylene Oxide

[00850000630048]

Ethylene Oxide

[00850000630048]

Ethylene Oxide

[00850000630048]

Ethylene Oxide

[00850000630048]

Ethylene Oxide

[00850000630048]

Ethylene Oxide

[00850000630048]

Ethylene Oxide

[00850000630048]

Ethylene Oxide

[00850000630048]

Ethylene Oxide

[00850000630048]

Ethylene Oxide

[00850000630048]

Ethylene Oxide

[00850000630048]

Ethylene Oxide

[00850000630048]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-16
• Device Publish Date: 2025-07-08

Devices Manufactured by ARCURO MEDICAL LTD

• 00850000630048 - SuperBall-RC 12 degrees Down: 2025-07-16
• 00850000630048 - SuperBall-RC 12 degrees Down: 2025-07-16
• 00850000630055 - SuperBall-RC 18 degrees Down: 2025-07-16
• 00850000630024 - SuperBall 24 degrees Up: 2025-07-08 The SuperBall™ Meniscal Repair System 24 Up is a single-patient and single-use device for repair procedures in the lateral and
• 00850000630031 - SuperBall 12 degrees Reverse: 2025-07-08 The SuperBall™ Meniscal Repair System 12 Reverse is a single-patient and single-use device for repair procedures in the latera
• 00850000630017 - SuperBall: 2020-06-23 The SuperBall Meniscal Repair System is a single patient, single use, an all-inside, all-suture meniscal repair device.