BIOMET® 360 32-360231

GUDID 00880304495364

Biomet Orthopedics, LLC

Knee tibia prosthesis trial

• Primary Device ID: 00880304495364
• NIH Device Record Key: ba05d7a1-4e45-4ef0-a892-0a1e716f44f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOMET® 360
• Version Model Number: 32-360231
• Catalog Number: 32-360231
• 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
• 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 Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304495364 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093293

FDA Product Code

• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

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

[00880304495364]

Moist Heat or Steam Sterilization

[00880304495364]

Moist Heat or Steam Sterilization

[00880304495364]

Moist Heat or Steam Sterilization

[00880304495364]

Moist Heat or Steam Sterilization

[00880304495364]

Moist Heat or Steam Sterilization

[00880304495364]

Moist Heat or Steam Sterilization

[00880304495364]

Moist Heat or Steam Sterilization

[00880304495364]

Moist Heat or Steam Sterilization

[00880304495364]

Moist Heat or Steam Sterilization

[00880304495364]

Moist Heat or Steam Sterilization

[00880304495364]

Moist Heat or Steam Sterilization

[00880304495364]

Moist Heat or Steam Sterilization

[00880304495364]

Moist Heat or Steam Sterilization

[00880304495364]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-09-21

On-Brand Devices [BIOMET® 360]

• 00880304496316: 32-360214
• 00880304496125: 32-360241
• 00880304496101: 32-360252
• 00880304496088: 32-360242
• 00880304496064: 32-360256
• 00880304496057: 32-360244
• 00880304496040: 32-360240
• 00880304496033: 32-360258
• 00880304496019: 32-360251
• 00880304496002: 32-360254
• 00880304495982: 32-360257
• 00880304495975: 32-360250
• 00880304495951: 32-360208
• 00880304495937: 32-360245
• 00880304495906: 32-360255
• 00880304495890: 32-360246
• 00880304495852: 32-360248
• 00880304495838: 32-360247
• 00880304495654: 32-360207
• 00880304495616: 32-360200
• 00880304495593: 32-360201
• 00880304495579: 32-360206
• 00880304495531: 32-360205
• 00880304495494: 32-360236
• 00880304495487: 32-360238
• 00880304495470: 32-360225
• 00880304495463: 32-360220
• 00880304495418: 32-360222
• 00880304495401: 32-360232
• 00880304495395: 32-360226
• 00880304495388: 32-360235
• 00880304495371: 32-360221
• 00880304495364: 32-360231
• 00880304495357: 32-360227
• 00880304495333: 32-360230
• 00880304495319: 32-360237
• 00880304495302: 32-360228
• 00880304494718: 32-360243
• 00880304494664: 32-360204
• 00880304494657: 32-360203
• 00880304494640: 32-360202
• 00880304494626: 32-360213
• 00880304494619: 32-360253
• 00880304494367: 32-360211
• 00880304494350: 32-360210
• 00880304494343: 32-360212
• 00880304494220: 32-360223
• 00880304494213: 32-360234
• 00880304494206: 32-360224
• 00880304494190: 32-360233