Comprehensive® Shoulder Instruments 41-406815

GUDID 00887868506604

Biomet Orthopedics, LLC

Medullary canal orthopaedic reamer, rigid

• Primary Device ID: 00887868506604
• NIH Device Record Key: 7de856f5-9e2c-48f7-b8dc-d09a871a2b61
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Comprehensive® Shoulder Instruments
• Version Model Number: 41-406815
• Catalog Number: 41-406815
• 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
• 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 Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868506604 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140390

FDA Product Code

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

Sterilization

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

[00887868506604]

Moist Heat or Steam Sterilization

[00887868506604]

Moist Heat or Steam Sterilization

[00887868506604]

Moist Heat or Steam Sterilization

[00887868506604]

Moist Heat or Steam Sterilization

[00887868506604]

Moist Heat or Steam Sterilization

[00887868506604]

Moist Heat or Steam Sterilization

[00887868506604]

Moist Heat or Steam Sterilization

[00887868506604]

Moist Heat or Steam Sterilization

[00887868506604]

Moist Heat or Steam Sterilization

[00887868506604]

Moist Heat or Steam Sterilization

[00887868506604]

Moist Heat or Steam Sterilization

[00887868506604]

Moist Heat or Steam Sterilization

[00887868506604]

Moist Heat or Steam Sterilization

[00887868506604]

Moist Heat or Steam Sterilization

[00887868506604]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-11
• Device Publish Date: 2022-04-02

On-Brand Devices [Comprehensive® Shoulder Instruments]

• 00880304456815: 407395
• 00880304456662: 407399
• 00880304456648: 407398
• 00880304456631: 41-406820
• 00880304456624: 41-406819
• 00880304456617: 41-406818
• 00880304452992: 41-406804
• 00880304451032: 41-406817
• 00880304451025: 41-406816
• 00880304451018: 41-406815
• 00880304451001: 41-406814
• 00880304450998: 41-406813
• 00880304450981: 41-406812
• 00880304450974: 41-406811
• 00880304450967: 41-406810
• 00880304450950: 41-406809
• 00880304450943: 41-406808
• 00880304450936: 41-406807
• 00880304450929: 41-406806
• 00880304450912: 41-406805
• 00887868506659: 41-406820
• 00880304456891: 407397
• 00880304456884: 407392
• 00880304456877: 407396
• 00887868505270: 406920
• 00887868506642: 41-406819
• 00887868506635: 41-406818
• 00887868506628: 41-406817
• 00887868506611: 41-406816
• 00887868506604: 41-406815
• 00887868506598: 41-406814
• 00887868506581: 41-406813
• 00887868506574: 41-406812
• 00887868506567: 41-406811
• 00887868506550: 41-406810
• 00887868506543: 41-406809
• 00887868506536: 41-406808
• 00887868506529: 41-406807
• 00887868506512: 41-406806
• 00887868506505: 41-406805
• 00887868506499: 41-406804
• 00887868506109: 407398
• 00887868506093: 407397
• 00887868506086: 407396
• 00887868506079: 407395
• 00887868506055: 407392
• 00887868506116: 407399