GLOBAL UNITE 110044530

GUDID 10603295430575

GLOBAL UNITE STANDARD HUMERAL HEAD SIZE 44mm x 12mm

DEPUY (IRELAND)

Stem-fixed humeral head prosthesis

• Primary Device ID: 10603295430575
• NIH Device Record Key: 5b533767-0214-4dc0-8a33-8e9cefea99dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GLOBAL UNITE
• Version Model Number: 1100-44-530
• Catalog Number: 110044530
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295430575 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133834

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-08-07
• Device Publish Date: 2016-12-22

On-Brand Devices [GLOBAL UNITE]

• 10603295383284: GLOBAL UNITE REVERSE EPIPHYSIS INSERTER
• 10603295430322: GLOBAL UNITE ANATOMIC IMPLANT HOLDER
• 10603295085188: GLOBAL UNITE IMPLANT HOLDER
• 10603295086123: GLOBAL UNITE EPIPHYSEAL REAMER SIZE 2
• 10603295086116: GLOBAL UNITE EPIPHYSEAL REAMER SIZE 1
• 10603295086109: GLOBAL UNITE EPIPHYSEAL REAMER TRIAL SIZE 2
• 10603295086093: GLOBAL UNITE EPIPHYSEAL REAMER TRIAL SIZE 1
• 10603295451754: GLOBAL UNITE FX REVERSE SHOULDER ARTHROPLASTY REVERSE TRAY 4
• 10603295451747: GLOBAL UNITE FX REVERSE SHOULDER ARTHROPLASTY REVERSE TRAY 3
• 10603295451730: GLOBAL UNITE FX REVERSE SHOULDER ARTHROPLASTY REVERSE TRAY 2
• 10603295451723: GLOBAL UNITE FX REVERSE SHOULDER ARTHROPLASTY REVERSE TRAY 1
• 10603295394105: GLOBAL UNITE ANATOMIC SET COMPLETE
• 10603295394068: GLOBAL UNITE FRACTURE SET COMPLETE
• 10603295394020: GLOBAL UNITE COMMON SET COMPLETE
• 10603295433569: GLOBAL UNITE ANATOMIC TRIAL PROXIMAL BODY 135 DEGREE SIZE 6/8
• 10603295433323: GLOBAL UNITE ANATOMIC TRIAL PROXIMAL BODY 142 DEGREE SIZE 6/8
• 10603295433316: GLOBAL UNITE ANATOMIC TRIAL PROXIMAL BODY 128 DEGREE SIZE 6/8
• 10603295416180: GLOBAL UNITE ANATOMIC TRIAL PROXIMAL BODY 142 DEGREE SIZE 16
• 10603295416173: GLOBAL UNITE ANATOMIC TRIAL PROXIMAL BODY 142 DEGREE SIZE 14
• 10603295416166: GLOBAL UNITE ANATOMIC TRIAL PROXIMAL BODY 142 DEGREE SIZE 12
• 10603295416159: GLOBAL UNITE ANATOMIC TRIAL PROXIMAL BODY 142 DEGREE SIZE 10
• 10603295416142: GLOBAL UNITE ANATOMIC TRIAL PROXIMAL BODY 128 DEGREE SIZE 16
• 10603295416135: GLOBAL UNITE ANATOMIC TRIAL PROXIMAL BODY 128 DEGREE SIZE 14
• 10603295416128: GLOBAL UNITE ANATOMIC TRIAL PROXIMAL BODY 128 DEGREE SIZE 12
• 10603295416111: GLOBAL UNITE ANATOMIC TRIAL PROXIMAL BODY 128 DEGREE SIZE 10
• 10603295416104: GLOBAL UNITE ANATOMIC TRIAL BODY SIZE 16 135 DEGREE
• 10603295416098: GLOBAL UNITE ANATOMIC TRIAL BODY SIZE 14 135 DEGREE
• 10603295416081: GLOBAL UNITE ANATOMIC TRIAL BODY SIZE 12 135 DEGREE
• 10603295416074: GLOBAL UNITE ANATOMIC TRIAL BODY SIZE 10 135 DEGREE
• 10603295085935: GLOBAL UNITE BODY TRIAL, SIZE 16 +5
• 10603295085928: GLOBAL UNITE BODY TRIAL, SIZE 16 +0
• 10603295085911: GLOBAL UNITE BODY TRIAL, SIZE 16 -5
• 10603295085799: GLOBAL UNITE BODY TRIAL, SIZE 14 +5
• 10603295085782: GLOBAL UNITE BODY TRIAL, SIZE 14 +0
• 10603295085775: GLOBAL UNITE BODY TRIAL, SIZE 14 -5
• 10603295085591: GLOBAL UNITE BODY TRIAL, SIZE 12 +5
• 10603295085584: GLOBAL UNITE BODY TRIAL, SIZE 12 +0
• 10603295085577: GLOBAL UNITE BODY TRIAL, SIZE 12 -5
• 10603295085553: GLOBAL UNITE BODY TRIAL, SIZE 10 +5
• 10603295085539: GLOBAL UNITE BODY TRIAL, SIZE 10 +0
• 10603295085515: GLOBAL UNITE BODY TRIAL, SIZE 10 -5
• 10603295085331: GLOBAL UNITE STANDARD STEM TRIAL, SIZE 16
• 10603295085324: GLOBAL UNITE STANDARD STEM TRIAL, SIZE 14
• 10603295085317: GLOBAL UNITE REVISION STEM TRIAL, 12
• 10603295085300: GLOBAL UNITE STANDARD STEM TRIAL, SIZE 12
• 10603295085270: GLOBAL UNITE STANDARD STEM TRIAL, SIZE 10
• 10603295085263: GLOBAL UNITE REVISION STEM TRIAL, SIZE 8
• 10603295085256: GLOBAL UNITE STANDARD STEM TRIAL, SIZE 8
• 10603295085249: GLOBAL UNITE REVISION STEM TRIAL, SIZE 6
• 10603295085997: GLOBAL UNITE GREATER FORCEPS