Versa-Dial® Shoulder System 407244

GUDID 00887868505515

Biomet Orthopedics, LLC

Humeral head prosthesis trial, reusable

• Primary Device ID: 00887868505515
• NIH Device Record Key: a80b8689-e2fd-42c3-bc6d-82a4d3dc0ef0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Versa-Dial® Shoulder System
• Version Model Number: 407244
• Catalog Number: 407244
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868505515 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060716

FDA Product Code

• MBF: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Sterilization

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

[00887868505515]

Moist Heat or Steam Sterilization

[00887868505515]

Moist Heat or Steam Sterilization

[00887868505515]

Moist Heat or Steam Sterilization

[00887868505515]

Moist Heat or Steam Sterilization

[00887868505515]

Moist Heat or Steam Sterilization

[00887868505515]

Moist Heat or Steam Sterilization

[00887868505515]

Moist Heat or Steam Sterilization

[00887868505515]

Moist Heat or Steam Sterilization

[00887868505515]

Moist Heat or Steam Sterilization

[00887868505515]

Moist Heat or Steam Sterilization

[00887868505515]

Moist Heat or Steam Sterilization

[00887868505515]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-16
• Device Publish Date: 2022-05-08

On-Brand Devices [Versa-Dial® Shoulder System]

• 00880304461444: 407293
• 00887868505669: 407298
• 00887868505652: 407297
• 00887868505645: 407296
• 00887868505621: 407281
• 00887868505614: 407280
• 00887868505607: 407278
• 00887868505591: 407276
• 00887868505584: 407268
• 00887868505577: 407266
• 00887868505560: 407258
• 00887868505553: 407256
• 00887868505546: 407254
• 00887868505539: 407248
• 00887868505522: 407246
• 00887868505515: 407244
• 00887868505508: 407242
• 00887868505492: 407234
• 00887868505485: 407232
• 00887868389979: 407236
• 00887868389948: 407224
• 00887868389931: 407222
• 00887868364815: 407264