REGENEREX 184607

GUDID 00880304461932

Biomet Orthopedics, LLC

Knee arthroplasty wedge

• Primary Device ID: 00880304461932
• NIH Device Record Key: 8f50395e-074c-46f1-9176-4a608275702c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REGENEREX
• Version Model Number: 184607
• Catalog Number: 184607
• 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

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304461932 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072336

FDA Product Code

• MBH: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-24

On-Brand Devices [REGENEREX]

• 00880304479920: 141269
• 00880304478145: 141277
• 00880304474949: 32-484620
• 00880304472655: 32-484626
• 00880304471474: 32-484606
• 00880304471467: 32-484602
• 00880304471450: 32-484605
• 00880304471443: 32-484607
• 00880304471436: 32-484603
• 00880304471429: 32-484608
• 00880304471412: 32-484601
• 00880304471405: 32-484604
• 00880304471382: 32-484625
• 00880304468238: 32-484623
• 00880304468221: 32-484624
• 00880304468214: 32-484627
• 00880304468207: 32-484622
• 00880304468191: 32-484628
• 00880304467088: 184601
• 00880304467057: 184605
• 00880304463646: 141273
• 00880304463639: 141276
• 00880304463622: 141271
• 00880304463615: 141272
• 00880304463608: 141275
• 00880304463592: 141270
• 00880304463585: 141274
• 00880304461970: 184602
• 00880304461963: 184603
• 00880304461956: 184604
• 00880304461949: 184606
• 00880304461932: 184607
• 00880304461925: 184608
• 00889024521018: SSI001041
• 00880304554429: 141357
• 00880304554412: 141356
• 00880304554405: 141355
• 00880304506084: 141358
• 00880304471399: 32-484615