545031500

GUDID 20603295174261

DEPUY CMW 1 GENTAMICIN Bone Cement 40g

DEPUY (IRELAND)

Orthopaedic cement, medicated

• Primary Device ID: 20603295174261
• NIH Device Record Key: dd06de52-03df-45b0-b908-23bb241ec0ac
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 5450-31-500
• Catalog Number: 545031500
• 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: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295174264 [Primary]
GS1	20603295174261 [Package]; Contains: 10603295174264; Package: PACKAGE [10 Units]; In Commercial Distribution
GS1	30603295174268 [Package]; Contains: 10603295174264; Package: CASE [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023103

FDA Product Code

• LOD: BONE CEMENT

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

Devices Manufactured by DEPUY (IRELAND)

• 10603295085980 - GLOBAL UNITE: 2026-02-09 GLOBAL UNITE COLLAR IMPACTOR
• 10603295088196 - GLOBAL ADVANTAGE: 2026-02-09 GLOBAL ADVANTAGE + IMPACTION BLOCK
• 10603295130192 - ATTUNE: 2026-02-09 ATTUNE TIBIAL IMPACTOR FIXED BEARING
• 10603295130208 - ATTUNE: 2026-02-09 ATTUNE TIBIAL IMPACTOR ROTATING PLATFORM
• 10603295130222 - ATTUNE: 2026-02-09 ATTUNE FEMORAL IMPACTOR
• 10603295395423 - ATTUNE: 2026-02-09 ATTUNE FIXED BEARING INSERT IMPACTOR
• 10603295431275 - DEPUY REACH: 2026-02-09 DEPUY REACH FEMORAL IMPLANT IMPACTOR
• 10603295431596 - DEPUY REACH: 2026-02-09 DEPUY REACH TIBIAL AND INSERT IMPACTOR