Winch Kyphoplasty ( 20 mm) 11 Gauge Balloon Catheter 900028

GUDID 08058964726407

Kyphoplasty Balloon Catheter

G21 SRL

Inflatable bone tamp Inflatable bone tamp Inflatable bone tamp Inflatable bone tamp Inflatable bone tamp Inflatable bone tamp Inflatable bone tamp Inflatable bone tamp Inflatable bone tamp Inflatable bone tamp Inflatable bone tamp Inflatable bone tamp Inflatable bone tamp Inflatable bone tamp Inflatable bone tamp Inflatable bone tamp Inflatable bone tamp

• Primary Device ID: 08058964726407
• NIH Device Record Key: ff8a4611-21d2-42ea-824c-2dd3540f57bb
• Commercial Distribution Discontinuation: 2017-11-13
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Winch Kyphoplasty ( 20 mm) 11 Gauge Balloon Catheter
• Version Model Number: 900028
• Catalog Number: 900028
• 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	08058964726407 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152557

FDA Product Code

• NDN: Cement, Bone, Vertebroplasty

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-03-06
• Device Publish Date: 2017-05-17

Devices Manufactured by G21 SRL

• 08058964727923 - SpaceFlex Acetabular Cup: 2023-04-19 The SpaceFlex Acetabular Cup consists of disposable cement spacer molds indicated for use to mold a temporary Acetabular cup rep
• 08058964726339 - Winch Kyphoplasty ( 15 mm) 11 Gauge Balloon Catheter: 2023-03-06 Kyphoplasty Balloon Catheter
• 08058964726407 - Winch Kyphoplasty ( 20 mm) 11 Gauge Balloon Catheter: 2023-03-06Kyphoplasty Balloon Catheter
• 08058964726407 - Winch Kyphoplasty ( 20 mm) 11 Gauge Balloon Catheter: 2023-03-06 Kyphoplasty Balloon Catheter
• 08058964726742 - FLEX DRILL 13G: 2022-06-10 Curette with curved distal end used to create a cavity inside the vertebra.
• 08058964724977 - SpaceFlex Shoulder: 2021-03-15 Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold a temporary hemi- shoulder replacemen
• 08058964726049 - SpaceFlex Shoulder: 2021-03-15 Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold a temporary hemi- shoulder replacemen
• 08058964726056 - SpaceFlex Shoulder: 2021-03-15 Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold a temporary hemi- shoulder replacemen
• 08058964726063 - SpaceFlex Shoulder: 2021-03-15 Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold a temporary hemi- shoulder replacemen