SMARTSET 3092040

GUDID 20603295168338

SmartSet HV High Viscosity Bone Cement 40g

DEPUY (IRELAND)

Orthopaedic cement, non-medicated Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial

• Primary Device ID: 20603295168338
• NIH Device Record Key: 61f94840-d101-4f45-8fa8-1104ef0054ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMARTSET
• Version Model Number: 3092-040
• Catalog Number: 3092040
• Company DUNS: 989365556
• Company Name: DEPUY (IRELAND)
• 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
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295168331 [Primary]
GS1	20603295168338 [Package]; Contains: 10603295168331; Package: PACKAGE [10 Units]; In Commercial Distribution
GS1	30603295168335 [Package]; Contains: 10603295168331; Package: CASE [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023012

FDA Product Code

• MBB: BONE CEMENT, ANTIBIOTIC

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: 2019-07-19
• Device Publish Date: 2015-09-24

On-Brand Devices [SMARTSET]

• 20603295174292: Smartset GMV HIGH PERFORMANCE GENTAMICIN Medium Viscosity Bone Cement 40g
• 20603295174285: Smartset GHV GENTAMICIN High Viscosity Bone Cement 40g
• 30603295168373: SmartSet HIGH PERFORMANCE MV Medium Viscosity Bone Cement 40g
• 20603295168369: SmartSet HIGH PERFORMANCE MV Medium Viscosity Bone Cement 20g
• 20603295168352: SmartSet ENDURANCE MV Medium Viscosity Bone Cement 80g
• 20603295168338: SmartSet HV High Viscosity Bone Cement 40g
• 30603295168328: SmartSet HV High Viscosity Bone Cement 20g