Winch Kyphoplasty Bilateral Kit 15 mm

GUDID 08058964726735

G21 SRL

Balloon kyphoplasty kit

• Primary Device ID: 08058964726735
• NIH Device Record Key: e87dadcc-c237-4182-9c3f-694b1d9490c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Winch Kyphoplasty Bilateral Kit 15 mm
• Version Model Number: 900016B
• Company DUNS: 431529195
• Company Name: G21 SRL
• 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08058964726735 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172214

FDA Product Code

• HRX: Arthroscope

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: 2025-03-06
• Device Publish Date: 2025-02-26

Devices Manufactured by G21 SRL

• 08058964728876 - CeMend Mold Base: 2025-03-26
• 08058964728883 - CeMend 8-42 mold insert press: 2025-03-26
• 08058964728890 - CeMend 10-42 mold insert press: 2025-03-26
• 08058964728906 - CeMend 10-48 mold insert press: 2025-03-26
• 08058964728913 - CeMend 12-42 mold insert press: 2025-03-26
• 08058964728920 - CeMend 12-48 mold insert press: 2025-03-26
• 08058964728937 - CeMend 14-48 mold insert press: 2025-03-26
• 08058964728944 - CeMend Base Compression Bolt: 2025-03-26