ReUnion R5350-4515

GUDID 07613327139570

Dual Radius Humeral Head

Howmedica Osteonics Corp.

Total shoulder prosthesis

• Primary Device ID: 07613327139570
• NIH Device Record Key: 916dd091-d1be-4efd-999c-ed6b48aef88c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ReUnion
• Version Model Number: R5350-4515
• Catalog Number: R5350-4515
• Company DUNS: 058311945
• Company Name: Howmedica Osteonics Corp.
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327139570 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955731

FDA Product Code

• HSD: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-24

On-Brand Devices [ReUnion]

• 07613327142655: Universal Humeral Neck Adapter
• 07613327139778: Dual Radius Humeral Head
• 07613327139723: Dual Radius Humeral Head
• 07613327139655: Dual Radius Humeral Head
• 07613327139648: Dual Radius Humeral Head
• 07613327139631: Dual Radius Humeral Head
• 07613327139624: Dual Radius Humeral Head
• 07613327139617: Dual Radius Humeral Head
• 07613327139600: Dual Radius Humeral Head
• 07613327139594: Dual Radius Humeral Head
• 07613327139587: Dual Radius Humeral Head
• 07613327139570: Dual Radius Humeral Head
• 07613327139563: Dual Radius Humeral Head
• 07613327139556: Dual Radius Humeral Head
• 07613327139549: Dual Radius Humeral Head
• 07613327139532: Dual Radius Humeral Head
• 07613327139525: Dual Radius Humeral Head
• 07613327139518: Dual Radius Humeral Head
• 07613327139501: Dual Radius Humeral Head
• 07613327139495: Dual Radius Humeral Head
• 07613327139488: Dual Radius Humeral Head
• 07613327139471: Dual Radius Humeral Head
• 07613327139464: Dual Radius Humeral Head
• 07613327139457: Dual Radius Humeral Head
• 07613327139440: Humeral Component
• 07613327139433: Dual Radius Humeral Head
• 07613327139426: Dual Radius Humeral Head
• 07613327139419: Humeral Component
• 07613327139402: Dual Radius Humeral Head
• 07613327139389: Humeral Component
• 07613327139372: Dual Radius Humeral Head
• 07613327139341: Humeral Component - Long Stem
• 07613327139334: Humeral Component - Long Stem
• 07613327139327: Humeral Component - Long Stem
• 07613327139310: Humeral Component
• 07613327139297: Humeral Component
• 07613327139280: Humeral Component
• 07613327139273: Humeral Component
• 07613327139259: Humeral Component
• 07613327139235: Humeral Component