Biomet® 32-341663

GUDID 00887868483509

Biomet Orthopedics, LLC

Knee tibia prosthesis trial, reusable

• Primary Device ID: 00887868483509
• NIH Device Record Key: dba058bf-f0cd-4278-8407-3d029a5f890a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biomet®
• Version Model Number: 32-341663
• Catalog Number: 32-341663
• 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

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 Identifiers

Device Issuing Agency	Device ID
GS1	00887868483509 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121149

FDA Product Code

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

Sterilization

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

[00887868483509]

Moist Heat or Steam Sterilization

[00887868483509]

Moist Heat or Steam Sterilization

[00887868483509]

Moist Heat or Steam Sterilization

[00887868483509]

Moist Heat or Steam Sterilization

[00887868483509]

Moist Heat or Steam Sterilization

[00887868483509]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-30
• Device Publish Date: 2022-06-22

On-Brand Devices [Biomet®]

• 00880304329218: 32-348015
• 00887868483196: 32-341533
• 00887868483189: 32-341532
• 00887868483097: 32-341310
• 00887868366130: 32-341314
• 00887868485992: 32-467355
• 00887868483516: 32-341664
• 00887868486029: 32-467360
• 00887868486012: 32-467358
• 00887868486005: 32-467356
• 00887868483738: 32-348015
• 00887868483172: 32-341530
• 00887868483165: 32-341528
• 00887868483158: 32-341526
• 00887868483141: 32-341518
• 00887868483134: 32-341514
• 00887868483080: 32-341268
• 00887868483073: 32-341267
• 00887868483066: 32-341266
• 00887868483059: 32-341265
• 00887868483042: 32-341264
• 00887868483035: 32-341263
• 00887868483028: 32-341262
• 00887868483011: 32-341261
• 00887868483004: 32-341260
• 00887868483608: 32-341702
• 00887868483592: 32-341701
• 00887868483585: 32-341700
• 00887868483578: 32-341699
• 00887868483561: 32-341698
• 00887868483554: 32-341697
• 00887868483547: 32-341696
• 00887868483530: 32-341694
• 00887868483523: 32-341692
• 00887868483509: 32-341663
• 00887868483493: 32-341662
• 00887868483486: 32-341661
• 00887868483479: 32-341660
• 00887868483462: 32-341659
• 00887868483455: 32-341658
• 00887868483448: 32-341657
• 00887868483431: 32-341656
• 00887868483424: 32-341654
• 00887868483417: 32-341652
• 00887868483400: 32-341642
• 00887868483394: 32-341641
• 00887868483387: 32-341640
• 00887868483370: 32-341639
• 00887868483363: 32-341638
• 00887868483356: 32-341637