S-ROM 136535000

GUDID 10603295327035

S-ROM M METAL ON METAL FEMORAL HEAD Diameter 36mm +12 11/13 TAPER

DEPUY (IRELAND)

Metallic femoral head prosthesis

• Primary Device ID: 10603295327035
• NIH Device Record Key: 60f0bb0a-5d7c-4197-9c47-5474c356a475
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: S-ROM
• Version Model Number: 1365-35-000
• Catalog Number: 136535000
• Company DUNS: 989365556
• Company Name: DEPUY (IRELAND)
• 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	10603295327035 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K851422

FDA Product Code

• LPH: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

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]

• 10603295327035: S-ROM M METAL ON METAL FEMORAL HEAD Diameter 36mm +12 11/13 TAPER
• 10603295033547: S-ROM M METAL ON METAL FEMORAL HEAD Diameter 36mm +12 11/13 TAPER