S-ROM NOILES 623421R

GUDID 10603295179511

S-ROM NOILES ROTATING HINGE FEMORAL ROTATING HINGE CEMENTED RIGHT X-SMALL

DEPUY (IRELAND)

Rotating hinged total knee prosthesis

• Primary Device ID: 10603295179511
• NIH Device Record Key: e03f89b5-3681-46dc-aa46-43849b39e4c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: S-ROM NOILES
• Version Model Number: 62-3421R
• Catalog Number: 623421R
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295179511 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241000

FDA Product Code

• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

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: 2024-12-09
• Device Publish Date: 2015-09-24

On-Brand Devices [S-ROM NOILES]

• 10603295179559: S-ROM NOILES ROTATING HINGE KNEE DISTAL FEM AUG BLOCK 10mm
• 10603295179542: S-ROM NOILES ROTATING HINGE KNEE DISTAL FEM AUG BLOCK 5mm
• 10603295179535: S-ROM NOILES ROTATING HINGE KNEE BUMPER MEDIUM
• 10603295179528: S-ROM NOILES ROTATING HINGE KNEE BUMPER SM/X-SM
• 10603295179511: S-ROM NOILES ROTATING HINGE FEMORAL ROTATING HINGE CEMENTED RIGHT X-SMALL
• 10603295179504: S-ROM NOILES ROTATING HINGE FEMORAL ROTATING HINGE CEMENTED LEFT X-SMALL
• 10603295179498: S-ROM NOILES ROTATING HINGE FEMORAL ROTATING HINGE CEMENTED RIGHT SMALL
• 10603295179481: S-ROM NOILES ROTATING HINGE FEMORAL ROTATING HINGE CEMENTED LEFT SMALL
• 10603295179474: S-ROM NOILES ROTATING HINGE FEMORAL ROTATING HINGE CEMENTED RIGHT MEDIUM
• 10603295179467: S-ROM NOILES ROTATING HINGE FEMORAL ROTATING HINGE CEMENTED LEFT MEDIUM
• 10603295179115: S-ROM NOILES ROTATING HINGE REPLACEMENT HINGE PIN MED
• 10603295179108: S-ROM NOILES ROTATING HINGE REPLACEMENT HINGE PIN X-SM/SM
• 10603295179122: S-ROM NOILES ROTATING HINGE KNEE HINGE BEARINGS