DELTA XTEND 140760015

GUDID 10603295272915

DELTA XTEND REVERSE SHOULDER SYSTEM Cementless Metaglene +15mm HA COATED CEMENTLESS

DEPUY FRANCE

Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis Total reverse shoulder prosthesis

• Primary Device ID: 10603295272915
• NIH Device Record Key: 4e17f22b-34b0-4228-b358-44e23df9d2ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DELTA XTEND
• Version Model Number: 1407-60-015
• Catalog Number: 140760015
• Company DUNS: 502491434
• Company Name: DEPUY FRANCE
• 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
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• 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
• 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
• 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	10603295272915 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120174

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: 2020-01-21
• Device Publish Date: 2020-01-13

On-Brand Devices [DELTA XTEND]

• 10603295256625: DELTA Xtend HUMERAL HEAD EXTRACTOR
• 10603295116639: DELTA Xtend PIN EXTRACTOR
• 10603295116363: DELTA Xtend HUMERAL IMPLANT DRIVER
• 10603295116417: DELTA Xtend V SHAPE GLENOID RETRACTOR
• 10603295027737: DELTA Xtend Cementless Metaglene HA
• 10603295027331: DELTA Xtend Cementless Modular Eccentric Epiphysis Sz2 / RIGHT HA
• 10603295027324: DELTA Xtend Cementless Modular Eccentric Epiphysis Sz2 / LEFT HA
• 10603295027317: DELTA Xtend Cementless Modular Centered Epiphysis Sz2 / CENT HA
• 10603295027300: DELTA Xtend Cementless Modular Eccentric Epiphysis Sz1 / RIGHT HA
• 10603295027294: DELTA Xtend Cementless Modular Eccentric Epiphysis Sz1 / LEFT HA
• 10603295027287: DELTA Xtend Cementless Modular Centered Epiphysis Sz1 / CENT HA
• 10603295027270: DELTA Xtend Cementless Modular Humeral Stem Dia 16 HA
• 10603295027225: DELTA Xtend Cementless Modular Humeral Stem Dia 14 HA
• 10603295027171: DELTA Xtend Cementless Modular Humeral Stem Dia 12 HA
• 10603295027126: DELTA Xtend Cementless Modular Humeral Stem Dia 10 HA
• 10603295272915: DELTA XTEND REVERSE SHOULDER SYSTEM Cementless Metaglene +15mm HA COATED CEMENTLESS
• 10603295272908: DELTA XTEND REVERSE SHOULDER SYSTEM Cementless Metaglene +10mm HA COATED CEMENTLESS
• 10603295116615: DELTA Xtend CUP EXTRACTION CLAMP