S-ROM 136516500

GUDID 10603295033141

S-ROM M METAL ON METAL FEMORAL HEAD Diameter 28mm +0 12/14 TAPER ULTAMET

DEPUY INTERNATIONAL LTD

Metallic femoral head prosthesis

• Primary Device ID: 10603295033141
• NIH Device Record Key: 0fefc424-4adf-4d21-a520-751183a9a518
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: S-ROM
• Version Model Number: 1365-16-500
• Catalog Number: 136516500
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295033141 [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