Winch Kyphoplasty Kit 8G 15 mm

GUDID 08058964727763

G21 SRL

Balloon kyphoplasty kit

• Primary Device ID: 08058964727763
• NIH Device Record Key: a503e45e-6764-4b91-88a6-fdc934aec0c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Winch Kyphoplasty Kit 8G 15 mm
• Version Model Number: 900207
• 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	08058964727763 [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

• 08058964726452 - Winch Kyphoplasty Kit 15 mm: 2025-03-06
• 08058964726469 - Winch Kyphoplasty Kit 20 mm: 2025-03-06
• 08058964726476 - WKK Traditional Access: 2025-03-06
• 08058964726483 - WKK First Access Needle: 2025-03-06
• 08058964726490 - WKK Cannulated Working Cannula: 2025-03-06
• 08058964726513 - WKK Guide Wire, Trocar and Round Tip 17G: 2025-03-06
• 08058964726735 - Winch Kyphoplasty Bilateral Kit 15 mm: 2025-03-06
• 08058964727589 - EasyWinch 15 mm: 2025-03-06