EMPHASYS 474101200

GUDID 10603295505402

EMPHASYS FEMORAL STEM COLLARED STANDARD OFFSET HA COATED CEMENTLESS 1 SO

DEPUY (IRELAND)

Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular Coated femoral stem prosthesis, modular

• Primary Device ID: 10603295505402
• NIH Device Record Key: a90040f8-2a83-492d-ba44-9b49343003b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EMPHASYS
• Version Model Number: 4741-01-200
• Catalog Number: 474101200
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295505402 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211657

FDA Product Code

• KWY: Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented

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: 2021-09-06
• Device Publish Date: 2021-08-28

On-Brand Devices [EMPHASYS]

• 10603295515562: EMPHASYS STARTER FEMORAL BROACH
• 10603295513803: EMPHASYS FEMORAL BROACH SIZE 12
• 10603295513797: EMPHASYS FEMORAL BROACH SIZE 11
• 10603295513780: EMPHASYS FEMORAL BROACH SIZE 10
• 10603295513773: EMPHASYS FEMORAL BROACH SIZE 9
• 10603295513766: EMPHASYS FEMORAL BROACH SIZE 8
• 10603295513759: EMPHASYS FEMORAL BROACH SIZE 7
• 10603295513742: EMPHASYS FEMORAL BROACH SIZE 6
• 10603295513735: EMPHASYS FEMORAL BROACH SIZE 5
• 10603295513728: EMPHASYS FEMORAL BROACH SIZE 4
• 10603295513711: EMPHASYS FEMORAL BROACH SIZE 3
• 10603295513704: EMPHASYS FEMORAL BROACH SIZE 2
• 10603295513698: EMPHASYS FEMORAL BROACH SIZE 1
• 10603295507024: EMPHASYS FEMORAL STEM COLLARLESS HIGH OFFSET HA COATED CEMENTLESS 12 HO
• 10603295507017: EMPHASYS FEMORAL STEM COLLARLESS HIGH OFFSET HA COATED CEMENTLESS 11 HO
• 10603295507000: EMPHASYS FEMORAL STEM COLLARLESS HIGH OFFSET HA COATED CEMENTLESS 10 HO
• 10603295506997: EMPHASYS FEMORAL STEM COLLARLESS HIGH OFFSET HA COATED CEMENTLESS 9 HO
• 10603295506980: EMPHASYS FEMORAL STEM COLLARLESS HIGH OFFSET HA COATED CEMENTLESS 8 HO
• 10603295506973: EMPHASYS FEMORAL STEM COLLARLESS HIGH OFFSET HA COATED CEMENTLESS 7 HO
• 10603295506966: EMPHASYS FEMORAL STEM COLLARLESS HIGH OFFSET HA COATED CEMENTLESS 6 HO
• 10603295506959: EMPHASYS FEMORAL STEM COLLARLESS HIGH OFFSET HA COATED CEMENTLESS 5 HO
• 10603295506942: EMPHASYS FEMORAL STEM COLLARLESS HIGH OFFSET HA COATED CEMENTLESS 4 HO
• 10603295506935: EMPHASYS FEMORAL STEM COLLARLESS HIGH OFFSET HA COATED CEMENTLESS 3 HO
• 10603295506928: EMPHASYS FEMORAL STEM COLLARLESS HIGH OFFSET HA COATED CEMENTLESS 2 HO
• 10603295506911: EMPHASYS FEMORAL STEM COLLARLESS HIGH OFFSET HA COATED CEMENTLESS 1 HO
• 10603295506898: EMPHASYS FEMORAL STEM COLLARLESS STANDARD OFFSET HA COATED CEMENTLESS 12 SO
• 10603295506881: EMPHASYS FEMORAL STEM COLLARLESS STANDARD OFFSET HA COATED CEMENTLESS 11 SO
• 10603295506874: EMPHASYS FEMORAL STEM COLLARLESS STANDARD OFFSET HA COATED CEMENTLESS 10 SO
• 10603295506850: EMPHASYS FEMORAL STEM COLLARLESS STANDARD OFFSET HA COATED CEMENTLESS 9 SO
• 10603295506843: EMPHASYS FEMORAL STEM COLLARLESS STANDARD OFFSET HA COATED CEMENTLESS 8 SO
• 10603295506836: EMPHASYS FEMORAL STEM COLLARLESS STANDARD OFFSET HA COATED CEMENTLESS 7 SO
• 10603295506829: EMPHASYS FEMORAL STEM COLLARLESS STANDARD OFFSET HA COATED CEMENTLESS 6 SO
• 10603295506812: EMPHASYS FEMORAL STEM COLLARLESS STANDARD OFFSET HA COATED CEMENTLESS 5 SO
• 10603295506805: EMPHASYS FEMORAL STEM COLLARLESS STANDARD OFFSET HA COATED CEMENTLESS 4 SO
• 10603295506799: EMPHASYS FEMORAL STEM COLLARLESS STANDARD OFFSET HA COATED CEMENTLESS 3 SO
• 10603295506782: EMPHASYS FEMORAL STEM COLLARLESS STANDARD OFFSET HA COATED CEMENTLESS 2 SO
• 10603295506775: EMPHASYS FEMORAL STEM COLLARLESS STANDARD OFFSET HA COATED CEMENTLESS 1 SO
• 10603295505624: EMPHASYS FEMORAL STEM COLLARED HIGH OFFSET HA COATED CEMENTLESS 12 HO
• 10603295505617: EMPHASYS FEMORAL STEM COLLARED HIGH OFFSET HA COATED CEMENTLESS 11 HO
• 10603295505600: EMPHASYS FEMORAL STEM COLLARED HIGH OFFSET HA COATED CEMENTLESS 10 HO
• 10603295505594: EMPHASYS FEMORAL STEM COLLARED HIGH OFFSET HA COATED CEMENTLESS 9 HO
• 10603295505587: EMPHASYS FEMORAL STEM COLLARED HIGH OFFSET HA COATED CEMENTLESS 8 HO
• 10603295505570: EMPHASYS FEMORAL STEM COLLARED HIGH OFFSET HA COATED CEMENTLESS 7 HO
• 10603295505563: EMPHASYS FEMORAL STEM COLLARED HIGH OFFSET HA COATED CEMENTLESS 6 HO
• 10603295505556: EMPHASYS FEMORAL STEM COLLARED HIGH OFFSET HA COATED CEMENTLESS 4 HO
• 10603295505549: EMPHASYS FEMORAL STEM COLLARED HIGH OFFSET HA COATED CEMENTLESS 3 HO
• 10603295505532: EMPHASYS FEMORAL STEM COLLARED HIGH OFFSET HA COATED CEMENTLESS 2 HO
• 10603295505525: EMPHASYS FEMORAL STEM COLLARED HIGH OFFSET HA COATED CEMENTLESS 1 HO
• 10603295505518: EMPHASYS FEMORAL STEM COLLARED STANDARD OFFSET HA COATED CEMENTLESS 12 SO
• 10603295505501: EMPHASYS FEMORAL STEM COLLARED STANDARD OFFSET HA COATED CEMENTLESS 11 SO