REACH® MODULAR HIP SYSTEM 108395

GUDID 00880304838963

Biomet Orthopedics, LLC

Coated femoral stem prosthesis, modular

• Primary Device ID: 00880304838963
• NIH Device Record Key: 2065d62a-3cc6-48f1-9d56-d86dc2fedd26
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REACH® MODULAR HIP SYSTEM
• Version Model Number: 108395
• Catalog Number: 108395
• 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	00880304838963 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030055

FDA Product Code

• LPH: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• LZO: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-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: 4
• Public Version Date: 2019-05-15
• Device Publish Date: 2016-10-14

On-Brand Devices [REACH® MODULAR HIP SYSTEM]

• 00880304839342: 21-108399
• 00880304839335: 21-108397
• 00880304839328: 21-108395
• 00880304839311: 21-108393
• 00880304839304: 21-108391
• 00880304839298: 21-108299
• 00880304839281: 21-108297
• 00880304839274: 21-108295
• 00880304839267: 21-108293
• 00880304839250: 21-108291
• 00880304838994: 108401
• 00880304838987: 108399
• 00880304838970: 108397
• 00880304838963: 108395
• 00880304838956: 108393
• 00880304838949: 108391
• 00880304838932: 108301
• 00880304838925: 108299
• 00880304838918: 108297
• 00880304838901: 108295
• 00880304838895: 108293
• 00880304838888: 108291