REACH MODULAR HIP SYSTEM 108397

GUDID 00880304196704

Biomet Orthopedics, LLC

Coated femoral stem prosthesis, modular

• Primary Device ID: 00880304196704
• NIH Device Record Key: eff91424-7551-45bb-9fe8-bf862578ec5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REACH MODULAR HIP SYSTEM
• Version Model Number: 108397
• Catalog Number: 108397
• 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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00880304196704 [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 [REACH MODULAR HIP SYSTEM]

• 00880304282124: 21-108399
• 00880304282117: 21-108397
• 00880304282100: 21-108393
• 00880304282094: 21-108391
• 00880304282087: 21-108293
• 00880304282070: 21-108291
• 00880304196728: 108401
• 00880304196711: 108399
• 00880304196704: 108397
• 00880304196681: 108395
• 00880304196674: 108393
• 00880304196667: 108391
• 00880304196476: 108301
• 00880304196452: 108295
• 00880304196438: 108293
• 00880304196421: 108291
• 00880304009530: 108299
• 00880304009035: 21-108395
• 00880304007673: 21-108297
• 00880304005662: 21-108299
• 00880304003293: 21-108295
• 00880304000131: 108297