VERSA-DIAL(TM) SHOULDER SYSTEM 407248

GUDID 00880304461543

Biomet Orthopedics, LLC

Humeral head prosthesis trial, reusable

• Primary Device ID: 00880304461543
• NIH Device Record Key: 955f9228-4c5e-4ca6-98e8-da63d392b5ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VERSA-DIAL(TM) SHOULDER SYSTEM
• Version Model Number: 407248
• Catalog Number: 407248
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304461543 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060716

FDA Product Code

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

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00880304461543]

Moist Heat or Steam Sterilization

[00880304461543]

Moist Heat or Steam Sterilization

[00880304461543]

Moist Heat or Steam Sterilization

[00880304461543]

Moist Heat or Steam Sterilization

[00880304461543]

Moist Heat or Steam Sterilization

[00880304461543]

Moist Heat or Steam Sterilization

[00880304461543]

Moist Heat or Steam Sterilization

[00880304461543]

Moist Heat or Steam Sterilization

[00880304461543]

Moist Heat or Steam Sterilization

[00880304461543]

Moist Heat or Steam Sterilization

[00880304461543]

Moist Heat or Steam Sterilization

[00880304461543]

Moist Heat or Steam Sterilization

[00880304461543]

Moist Heat or Steam Sterilization

[00880304461543]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-02-07
• Device Publish Date: 2017-07-28

On-Brand Devices [VERSA-DIAL(TM) SHOULDER SYSTEM]

• 00880304462137: 407201
• 00880304461581: 407232
• 00880304461574: 407258
• 00880304461567: 407234
• 00880304461550: 407244
• 00880304461543: 407248
• 00880304461536: 407254
• 00880304461529: 407256
• 00880304461512: 407242
• 00880304461505: 407236
• 00880304457386: 407296
• 00880304456860: 407281
• 00880304456846: 407280
• 00880304456778: 407266
• 00880304456761: 407246
• 00880304456754: 407268
• 00880304456747: 407278
• 00880304456730: 407276
• 00880304456723: 407224
• 00880304456716: 407222
• 00880304456709: 407264
• 00880304456655: 407298