DELTA XTEND 230766138

GUDID 10603295507284

DELTA XTEND Lateralized Glenosphere +6mm Trial Standard diameter 38mm

DEPUY (IRELAND)

Reverse shoulder head prosthesis trial

• Primary Device ID: 10603295507284
• NIH Device Record Key: 7eba5ba7-658d-4dfe-9afc-a4d868c34f62
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DELTA XTEND
• Version Model Number: 2307-66-138
• Catalog Number: 230766138
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295507284 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183077

FDA Product Code

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

Sterilization

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

[10603295507284]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-30
• Device Publish Date: 2019-05-22

On-Brand Devices [DELTA XTEND]

• 10603295507147: DELTA XTEND 145 Degree EPI / LATERALIZED LID
• 10603295507130: DELTA XTEND 145 Degree EPI / LATERALIZED CASE
• 10603295507345: DELTA XTEND Lateralized Glenosphere +8mm Trial Standard diameter 42mm
• 10603295507338: DELTA XTEND Lateralized Glenosphere +6mm Trial Standard diameter 42mm
• 10603295507321: DELTA XTEND Lateralized Glenosphere +4mm Trial Standard diameter 42mm
• 10603295507314: DELTA XTEND Lateralized Glenosphere +2mm Trial Standard diameter 42mm
• 10603295507307: DELTA XTEND Lateralized Glenosphere +0mm Trial Standard diameter 42mm
• 10603295507291: DELTA XTEND Lateralized Glenosphere +8mm Trial Standard diameter 38mm
• 10603295507284: DELTA XTEND Lateralized Glenosphere +6mm Trial Standard diameter 38mm
• 10603295507277: DELTA XTEND Lateralized Glenosphere +2mm Trial Eccentric diameter 38mm
• 10603295507260: DELTA XTEND Lateralized Glenosphere +0mm Trial Eccentric diameter 38mm
• 10603295507253: DELTA XTEND Lateralized Glenosphere +4mm Trial Standard diameter 38mm
• 10603295507246: DELTA XTEND Lateralized Glenosphere +2mm Trial Standard diameter 38mm
• 10603295507239: DELTA XTEND Lateralized Glenosphere +0mm Trial Standard diameter 38mm
• 10603295507222: DELTA XTEND Lateralized Glenosphere +8mm Trial Eccentric diameter 42mm
• 10603295507215: DELTA XTEND Lateralized Glenosphere +6mm Trial Eccentric diameter 42mm
• 10603295507208: DELTA XTEND Lateralized Glenosphere +4mm Trial Eccentric diameter 42mm
• 10603295507192: DELTA XTEND Lateralized Glenosphere +2mm Trial Eccentric diameter 42mm
• 10603295507185: DELTA XTEND Lateralized Glenosphere +0mm Trial Eccentric diameter 42mm
• 10603295507178: DELTA XTEND Lateralized Glenosphere +8mm Trial Eccentric diameter 38mm
• 10603295507161: DELTA XTEND Lateralized Glenosphere +6mm Trial Eccentric diameter 38mm
• 10603295507154: DELTA XTEND Lateralized Glenosphere +4mm Trial Eccentric diameter 38mm
• 10603295502647: DELTA XTEND Lateralized Glenosphere +6mm Eccentric 042mm
• 10603295502630: DELTA XTEND Lateralized Glenosphere +6mm Eccentric 038mm
• 10603295502623: DELTA XTEND Lateralized Glenosphere +6mm Standard 042mm
• 10603295502616: DELTA XTEND Lateralized Glenosphere +6mm Standard 038mm
• 10603295502609: DELTA XTEND Lateralized Glenosphere +0mm Eccentric 042mm
• 10603295502593: DELTA XTEND Lateralized Glenosphere +0mm Eccentric 038mm
• 10603295502562: DELTA XTEND Lateralized Glenosphere +0mm Standard 042mm
• 10603295502555: DELTA XTEND Lateralized Glenosphere +0mm Standard 038mm
• 10603295502548: DELTA XTEND Lateralized Glenosphere +8mm Standard 042mm
• 10603295502531: DELTA XTEND Lateralized Glenosphere +8mm Standard 038mm
• 10603295502524: DELTA XTEND Lateralized Glenosphere +8mm Eccentric 042mm
• 10603295502517: DELTA XTEND Lateralized Glenosphere +8mm Eccentric 038mm
• 10603295502500: DELTA XTEND Lateralized Glenosphere +2mm Standard 042mm
• 10603295502494: DELTA XTEND Lateralized Glenosphere +2mm Standard 038mm
• 10603295502487: DELTA XTEND Lateralized Glenosphere +4mm Eccentric 042mm
• 10603295502470: DELTA XTEND Lateralized Glenosphere +4mm Eccentric 038mm
• 10603295502463: DELTA XTEND Lateralized Glenosphere +4mm Standard 042mm
• 10603295502456: DELTA XTEND Lateralized Glenosphere +4mm Standard 038mm
• 10603295502449: DELTA XTEND Lateralized Glenosphere +2mm Eccentric 042mm
• 10603295502432: DELTA XTEND Lateralized Glenosphere +2mm Eccentric 038mm
• 10603295423652: DELTA XTEND Cementless Metaglene +15mm HA
• 10603295423645: DELTA XTEND Cementless Metaglene +10mm HA
• 10603295518853: DELTA XTEND MODULAR ECCENTRIC 145 EPIPHYSIS TRIAL RIGHT Size 2
• 10603295518846: DELTA XTEND MODULAR ECCENTRIC 145 EPIPHYSIS TRIAL LEFT Size 2
• 10603295518839: DELTA XTEND MODULAR ECCENTRIC 145 EPIPHYSIS TRIAL RIGHT Size 1
• 10603295518822: DELTA XTEND MODULAR ECCENTRIC 145 EPIPHYSIS TRIAL LEFT Size 1
• 10603295518815: DELTA XTEND MODULAR ECCENTRIC 145 EPIPHYSIS TRIAL CENTERED Size 2
• 10603295518808: DELTA XTEND MODULAR ECCENTRIC 145 EPIPHYSIS TRIAL CENTERED Size 1