COMPREHENSIVE INSTRUMENTS 110004200

GUDID 00880304539310

Biomet Orthopedics, LLC

Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Orthopaedic implant/instrument adaptor, reusable Orthopaedic implant/instrument adaptor, reusable Orthopaedic implant/instrument adaptor, reusable Orthopaedic implant/instrument adaptor, reusable Orthopaedic implant/instrument adaptor, reusable Orthopaedic implant/instrument adaptor, reusable Orthopaedic implant/instrument adaptor, reusable Orthopaedic implant/instrument adaptor, reusable Orthopaedic implant/instrument adaptor, reusable Orthopaedic implant/instrument adaptor, reusable Orthopaedic implant/instrument adaptor, reusable Orthopaedic implant/instrument adaptor, reusable Orthopaedic implant/instrument adaptor, reusable Orthopaedic implant-instrument extension adaptor, reusable Orthopaedic implant-instrument extension adaptor, reusable Orthopaedic implant-instrument extension adaptor, reusable Orthopaedic implant-instrument extension adaptor, reusable Orthopaedic implant-instrument extension adaptor, reusable Orthopaedic implant-instrument extension adaptor, reusable Orthopaedic implant-instrument extension adaptor, reusable Orthopaedic implant-instrument extension adaptor, reusable Orthopaedic implant-instrument extension adaptor, reusable Orthopaedic implant-instrument extension adaptor, reusable Orthopaedic implant-instrument extension adaptor, reusable Orthopaedic implant-instrument extension adaptor, reusable Orthopaedic implant-instrument extension adaptor, reusable Orthopaedic implant-instrument extension adaptor, reusable

• Primary Device ID: 00880304539310
• NIH Device Record Key: b0b369bf-49b9-465c-a2da-9a0333aca59c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COMPREHENSIVE INSTRUMENTS
• Version Model Number: 110004200
• Catalog Number: 110004200
• 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: 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
• 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
• 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	00880304539310 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060694

FDA Product Code

• KWT: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Sterilization

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

[00880304539310]

Moist Heat or Steam Sterilization

[00880304539310]

Moist Heat or Steam Sterilization

[00880304539310]

Moist Heat or Steam Sterilization

[00880304539310]

Moist Heat or Steam Sterilization

[00880304539310]

Moist Heat or Steam Sterilization

[00880304539310]

Moist Heat or Steam Sterilization

[00880304539310]

Moist Heat or Steam Sterilization

[00880304539310]

Moist Heat or Steam Sterilization

[00880304539310]

Moist Heat or Steam Sterilization

[00880304539310]

Moist Heat or Steam Sterilization

[00880304539310]

Moist Heat or Steam Sterilization

[00880304539310]

Moist Heat or Steam Sterilization

[00880304539310]

Moist Heat or Steam Sterilization

[00880304539310]

Moist Heat or Steam Sterilization

[00880304539310]

Moist Heat or Steam Sterilization

[00880304539310]

Moist Heat or Steam Sterilization

[00880304539310]

Moist Heat or Steam Sterilization

[00880304539310]

Moist Heat or Steam Sterilization

[00880304539310]

Moist Heat or Steam Sterilization

[00880304539310]

Moist Heat or Steam Sterilization

[00880304539310]

Moist Heat or Steam Sterilization

[00880304539310]

Moist Heat or Steam Sterilization

[00880304539310]

Moist Heat or Steam Sterilization

[00880304539310]

Moist Heat or Steam Sterilization

[00880304539310]

Moist Heat or Steam Sterilization

[00880304539310]

Moist Heat or Steam Sterilization

[00880304539310]

Moist Heat or Steam Sterilization

[00880304539310]

Moist Heat or Steam Sterilization

[00880304539310]

Moist Heat or Steam Sterilization

[00880304539310]

Moist Heat or Steam Sterilization

[00880304539310]

Moist Heat or Steam Sterilization

[00880304539310]

Moist Heat or Steam Sterilization

[00880304539310]

Moist Heat or Steam Sterilization

[00880304539310]

Moist Heat or Steam Sterilization

[00880304539310]

Moist Heat or Steam Sterilization

[00880304539310]

Moist Heat or Steam Sterilization

[00880304539310]

Moist Heat or Steam Sterilization

[00880304539310]

Moist Heat or Steam Sterilization

[00880304539310]

Moist Heat or Steam Sterilization

[00880304539310]

Moist Heat or Steam Sterilization

[00880304539310]

Moist Heat or Steam Sterilization

[00880304539310]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-28

On-Brand Devices [COMPREHENSIVE INSTRUMENTS]

• 00880304539433: 110003472
• 00880304539426: 110003483
• 00880304539419: 110003478
• 00880304539402: 110003476
• 00880304539396: 110003474
• 00880304539389: 110004265
• 00880304539372: 010001791
• 00880304539365: 010001800
• 00880304539358: 010001801
• 00880304539341: 010001799
• 00880304539334: 010001790
• 00880304539327: 010001792
• 00880304539310: 110004200
• 00880304539303: 110003486
• 00880304539280: 110003488
• 00880304537781: 110003484
• 00880304537026: 110003489
• 00880304564381: 010001789
• 00880304564374: 010001788
• 00880304564367: 010001787