STAGEONE 431408

GUDID 00880304551015

Biomet Orthopedics, LLC

Orthopaedic cement spacer mould

• Primary Device ID: 00880304551015
• NIH Device Record Key: f261bee3-6be2-4a7f-bb56-f000d0e43166
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STAGEONE
• Version Model Number: 431408
• Catalog Number: 431408
• 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	00880304551015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131135

FDA Product Code

• KWS: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

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: 2019-09-23
• Device Publish Date: 2016-09-26

On-Brand Devices [STAGEONE]

• 00880304551114: 431414
• 00880304551107: 431406
• 00880304551091: 431410
• 00880304551015: 431408
• 00880304551008: 431412
• 00880304447172: 431213
• 00880304447165: 431207
• 00880304447158: 431217
• 00880304447141: 431209
• 00880304007031: 433180
• 00880304002661: 433170
• 00880304002647: 433175
• 00880304002630: 432170
• 00880304001831: 432160
• 00880304001824: 433165
• 00880304001183: 432165
• 00880304001176: 432175