3.5MM MENISCUS CUTTER 908516

GUDID 00880304410435

Biomet Orthopedics, LLC

Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use Arthroscopic shaver system blade, single-use

• Primary Device ID: 00880304410435
• NIH Device Record Key: 9f5a733d-0836-4b68-a2bd-42a890f1e4ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3.5MM MENISCUS CUTTER
• Version Model Number: 908516
• Catalog Number: 908516
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, LLC
• Device Count: 5
• 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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00880304410435 [Primary]
GS1	70880304410434 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K920800

FDA Product Code

• HRX: Arthroscope

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: 2017-08-04

Devices Manufactured by Biomet Orthopedics, LLC

• 00887868004087 - PRIMARY TREPHINE: 2024-04-03
• 00887868004094 - BUSHING: 2024-04-03
• 00887868004100 - SECONDARY TREPHINE: 2024-04-03
• 00887868048272 - TREPHINE: 2024-04-03
• 00887868048289 - TREPHINE: 2024-04-03
• 00887868048296 - TREPHINE: 2024-04-03
• 00887868048302 - TREPHINE: 2024-04-03
• 00880304658387 - Compress®: 2024-03-11