EMPHASYS 474208200

GUDID 10603295505587

EMPHASYS FEMORAL STEM COLLARED HIGH OFFSET HA COATED CEMENTLESS 8 HO

DEPUY (IRELAND)

Coated femoral stem prosthesis, modular

• Primary Device ID: 10603295505587
• NIH Device Record Key: 3947366a-3292-40b5-9c99-a4b2c6ede169
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EMPHASYS
• Version Model Number: 4742-08-200
• Catalog Number: 474208200
• 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
• 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	10603295505587 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211657

FDA Product Code

• LZO: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, 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