COMPREHENSIVE INSTRUMENTATION 405906

GUDID 00880304469778

Biomet Orthopedics, LLC

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: 00880304469778
• NIH Device Record Key: d84d97a4-563f-4c07-b9af-2834cc94d58b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COMPREHENSIVE INSTRUMENTATION
• Version Model Number: 405906
• Catalog Number: 405906
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304469778 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193373

FDA Product Code

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

Sterilization

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

[00880304469778]

Moist Heat or Steam Sterilization

[00880304469778]

Moist Heat or Steam Sterilization

[00880304469778]

Moist Heat or Steam Sterilization

[00880304469778]

Moist Heat or Steam Sterilization

[00880304469778]

Moist Heat or Steam Sterilization

[00880304469778]

Moist Heat or Steam Sterilization

[00880304469778]

Moist Heat or Steam Sterilization

[00880304469778]

Moist Heat or Steam Sterilization

[00880304469778]

Moist Heat or Steam Sterilization

[00880304469778]

Moist Heat or Steam Sterilization

[00880304469778]

Moist Heat or Steam Sterilization

[00880304469778]

Moist Heat or Steam Sterilization

[00880304469778]

Moist Heat or Steam Sterilization

[00880304469778]

Moist Heat or Steam Sterilization

[00880304469778]

Moist Heat or Steam Sterilization

[00880304469778]

Moist Heat or Steam Sterilization

[00880304469778]

Moist Heat or Steam Sterilization

[00880304469778]

Moist Heat or Steam Sterilization

[00880304469778]

Moist Heat or Steam Sterilization

[00880304469778]

Moist Heat or Steam Sterilization

[00880304469778]

Moist Heat or Steam Sterilization

[00880304469778]

Moist Heat or Steam Sterilization

[00880304469778]

Moist Heat or Steam Sterilization

[00880304469778]

Moist Heat or Steam Sterilization

[00880304469778]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-07-28

On-Brand Devices [COMPREHENSIVE INSTRUMENTATION]

• 00880304731752: 110016882
• 00880304731523: 110029136
• 00880304731509: 110028880
• 00880304731394: 110028879
• 00880304731387: 110028878
• 00880304731332: 110028439
• 00880304731325: 110028438
• 00880304716209: 110016888
• 00880304716193: 110016887
• 00880304716186: 110016886
• 00880304716179: 110016885
• 00880304716162: 110016884
• 00880304716155: 110016883
• 00880304702769: 110017268
• 00880304472792: 405990
• 00880304472785: 405988
• 00880304471498: 405948
• 00880304471191: 405806
• 00880304471023: 405965
• 00880304470385: 405970
• 00880304470378: 405975
• 00880304470279: 405960
• 00880304470262: 405950
• 00880304470255: 405998
• 00880304470248: 405945
• 00880304470033: 405985
• 00880304470026: 405980
• 00880304470019: 405968
• 00880304470002: 405955
• 00880304469990: 405978
• 00880304469983: 405995
• 00880304469976: 405890
• 00880304469914: 405887
• 00880304469907: 405832
• 00880304469891: 405808
• 00880304469884: 405895
• 00880304469877: 405889
• 00880304469860: 405883
• 00880304469853: 405908
• 00880304469846: 405899
• 00880304469815: 405813
• 00880304469808: 405940
• 00880304469792: 405816
• 00880304469785: 405826
• 00880304469778: 405906
• 00880304469761: 405810
• 00880304469754: 405823
• 00880304469747: 405902
• 00880304469730: 405820
• 00880304469716: 405802