VBB 03804500S

GUDID H98103804500S0

VERTEBRAL BODY BALLOON/SMALL- STERILE

Synthes GmbH

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: H98103804500S0
• NIH Device Record Key: 110bff1e-2872-4a5c-ac30-f2146cfa31da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VBB
• Version Model Number: 03.804.500S
• Catalog Number: 03804500S
• Company DUNS: 486711679
• Company Name: Synthes GmbH
• 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

Customer Support Contacts

• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034722603 [Primary]
HIBCC	H98103804500S0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110604

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: 2022-04-26
• Device Publish Date: 2015-09-14

On-Brand Devices [VBB]

• H98103804502S0: VERTEBRAL BODY BALLOON/LARGE- STERILE
• H98103804501S0: VERTEBRAL BODY BALLOON/MEDIUM- STERILE
• H98103804500S0: VERTEBRAL BODY BALLOON/SMALL- STERILE