DURALOC 124580053

GUDID 10603295019626

DURALOC SHELL SECTOR 60mm OD CEMENTLESS

DEPUY (IRELAND)

Acetabular shell

• Primary Device ID: 10603295019626
• NIH Device Record Key: bf8060cb-f1c6-4c3d-b109-a16c258a0818
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DURALOC
• Version Model Number: 1245-80-053
• Catalog Number: 124580053
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295019626 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K900832

FDA Product Code

• JDI: Prosthesis, hip, semi-constrained, metal/polymer, cemented

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: 2020-09-09
• Device Publish Date: 2015-09-24

On-Brand Devices [DURALOC]

• 10603295019671: DURALOC SHELL SECTOR 66mm OD CEMENTLESS
• 10603295019664: DURALOC SHELL SECTOR 64mm OD CEMENTLESS
• 10603295019657: DURALOC SHELL SECTOR 50mm OD CEMENTLESS
• 10603295019640: DURALOC SHELL SECTOR 48mm OD CEMENTLESS
• 10603295019633: DURALOC SHELL SECTOR 62mm OD CEMENTLESS
• 10603295019626: DURALOC SHELL SECTOR 60mm OD CEMENTLESS
• 10603295019619: DURALOC SHELL SECTOR 58mm OD CEMENTLESS
• 10603295019602: DURALOC SHELL SECTOR 56mm OD CEMENTLESS
• 10603295019596: DURALOC SHELL SECTOR 54mm OD CEMENTLESS
• 10603295019589: DURALOC SHELL SECTOR 52mm OD CEMENTLESS