S-ROM 522022

GUDID 10603295170778

S-ROM FEMORAL HEAD 11/13 TAPER Diameter 22.225mm +0

DEPUY INTERNATIONAL LTD

Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis Metallic femoral head prosthesis

• Primary Device ID: 10603295170778
• NIH Device Record Key: 906cb93f-aab4-4c08-969f-d436bbeb27af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: S-ROM
• Version Model Number: 52-2022
• Catalog Number: 522022
• Company DUNS: 896498813
• Company Name: DEPUY INTERNATIONAL LTD
• 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
• 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	10603295170778 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K851422

FDA Product Code

• JDI: Prosthesis, hip, 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: 2020-04-06
• Device Publish Date: 2015-09-24

On-Brand Devices [S-ROM]

• 10603295219712: S-ROM A STEM IMPACTOR/INSERTER
• 10603295218869: S-ROM FEMORAL HEAD 11/13 TAPER Diameter 32mm +9
• 10603295218852: S-ROM FEMORAL HEAD 11/13 TAPER Diameter 32mm +3
• 10603295218845: S-ROM FEMORAL HEAD 11/13 TAPER Diameter 28mm +9
• 10603295218838: S-ROM FEMORAL HEAD 11/13 TAPER Diameter 28mm +3
• 10603295170846: S-ROM FEMORAL HEAD 11/13 TAPER Diameter 32mm +12
• 10603295170839: S-ROM FEMORAL HEAD 11/13 TAPER Diameter 32mm +6
• 10603295170822: S-ROM FEMORAL HEAD 11/13 TAPER Diameter 32mm +0
• 10603295170815: S-ROM FEMORAL HEAD 11/13 TAPER Diameter 28mm +12
• 10603295170808: S-ROM FEMORAL HEAD 11/13 TAPER Diameter 28mm +6
• 10603295170792: S-ROM FEMORAL HEAD 11/13 TAPER Diameter 28mm +0
• 10603295170778: S-ROM FEMORAL HEAD 11/13 TAPER Diameter 22.225mm +0
• 10603295033141: S-ROM M METAL ON METAL FEMORAL HEAD Diameter 28mm +0 12/14 TAPER ULTAMET