GLOBAL GLOBAL UNITE 110014800

GUDID 10603295523376

GLOBAL GLOBAL UNITE POROCOAT COATING SHORT STEM CEMENTLESS SIZE 14, 57mm

DEPUY (IRELAND)

Coated shoulder humeral stem prosthesis

• Primary Device ID: 10603295523376
• NIH Device Record Key: acc388e7-f482-4897-bbfd-603e2b6a0672
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GLOBAL GLOBAL UNITE
• Version Model Number: 1100-14-800
• Catalog Number: 110014800
• Company DUNS: 989365556
• Company Name: DEPUY (IRELAND)
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295523376 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202098

FDA Product Code

• KWS: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-16
• Device Publish Date: 2020-12-08

On-Brand Devices [GLOBAL GLOBAL UNITE]

• 10603295523383: GLOBAL GLOBAL UNITE POROCOAT COATING SHORT STEM CEMENTLESS SIZE 16, 61mm
• 10603295523376: GLOBAL GLOBAL UNITE POROCOAT COATING SHORT STEM CEMENTLESS SIZE 14, 57mm
• 10603295523369: GLOBAL GLOBAL UNITE POROCOAT COATING SHORT STEM CEMENTLESS SIZE 12, 49mm
• 10603295523352: GLOBAL GLOBAL UNITE POROCOAT COATING SHORT STEM CEMENTLESS SIZE 10, 44mm
• 10603295523406: GLOBAL GLOBAL UNITE POROCOAT COATING SHORT STEM CEMENTLESS SIZE 8, 44mm