DURALOC 124580054

GUDID 10603295019633

DURALOC SHELL SECTOR 62mm OD CEMENTLESS

DEPUY (IRELAND)

Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell

• Primary Device ID: 10603295019633
• NIH Device Record Key: a03b10f3-ec72-4c12-81f5-1d5c44d385b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DURALOC
• Version Model Number: 1245-80-054
• Catalog Number: 124580054
• 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	10603295019633 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K900832

FDA Product Code

• LPH: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

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