RIM-LOC HIP SYSTEM 105428

GUDID 00880304191693

Biomet Orthopedics, LLC

Acetabular shell

• Primary Device ID: 00880304191693
• NIH Device Record Key: d5090c1a-51b4-4744-a94b-e1dcdfb94522
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RIM-LOC HIP SYSTEM
• Version Model Number: 105428
• Catalog Number: 105428
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, LLC
• 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)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304191693 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030055

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-24

On-Brand Devices [RIM-LOC HIP SYSTEM]

• 00880304201125: 11-105236
• 00880304201118: 11-105234
• 00880304201088: 11-105223
• 00880304201071: 11-105218
• 00880304201064: 11-105217
• 00880304201057: 11-105216
• 00880304201040: 11-105215
• 00880304201033: 11-105214
• 00880304201026: 11-105213
• 00880304201019: 11-105212
• 00880304201002: 11-105208
• 00880304200999: 11-105207
• 00880304200982: 11-105206
• 00880304200975: 11-105205
• 00880304200968: 11-105204
• 00880304200951: 11-105203
• 00880304200944: 11-105202
• 00880304200937: 11-105201
• 00880304191693: 105428
• 00880304191686: 105427
• 00880304191679: 105426
• 00880304191662: 105425
• 00880304191655: 105424
• 00880304191648: 105423
• 00880304191631: 105422
• 00880304191624: 105421
• 00880304191617: 105420