Comprehensive® Instrumentation 110029303

GUDID 00887868470134

Biomet Orthopedics, LLC

Humeral head prosthesis trial, reusable

• Primary Device ID: 00887868470134
• NIH Device Record Key: 57b18772-3851-4f59-a734-ef11afe9f197
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Comprehensive® Instrumentation
• Version Model Number: 110029303
• Catalog Number: 110029303
• 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	00887868470134 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080642

FDA Product Code

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

Sterilization

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

[00887868470134]

Moist Heat or Steam Sterilization

[00887868470134]

Moist Heat or Steam Sterilization

[00887868470134]

Moist Heat or Steam Sterilization

[00887868470134]

Moist Heat or Steam Sterilization

[00887868470134]

Moist Heat or Steam Sterilization

[00887868470134]

Moist Heat or Steam Sterilization

[00887868470134]

Moist Heat or Steam Sterilization

[00887868470134]

Moist Heat or Steam Sterilization

[00887868470134]

Moist Heat or Steam Sterilization

[00887868470134]

Moist Heat or Steam Sterilization

[00887868470134]

Moist Heat or Steam Sterilization

[00887868470134]

Moist Heat or Steam Sterilization

[00887868470134]

Moist Heat or Steam Sterilization

[00887868470134]

Moist Heat or Steam Sterilization

[00887868470134]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-10
• Device Publish Date: 2021-04-30

On-Brand Devices [Comprehensive® Instrumentation]

• 00880304737273: 110027886
• 00880304737266: 110027742
• 00880304734906: 110025762
• 00880304734746: 110029307
• 00880304734739: 110029306
• 00880304734722: 110029305
• 00880304734715: 110029304
• 00880304734708: 110029303
• 00880304734692: 110029302
• 00880304734661: 110028923
• 00880304734654: 110028922
• 00880304734647: 110028921
• 00880304734630: 110028920
• 00880304734623: 110028919
• 00880304734616: 110028915
• 00880304734562: 110028522
• 00887868466533: 110017268
• 00887868470028: 110028880
• 00887868470011: 110028879
• 00887868469992: 110028439
• 00887868469985: 110028438
• 00887868469978: 110028055
• 00887868469961: 110027886
• 00887868469947: 110027742
• 00887868469855: 110025762
• 00887868363351: 110028878
• 00887868363337: 110028441
• 00887868363320: 110028440
• 00887868470172: 110029307
• 00887868470165: 110029306
• 00887868470158: 110029305
• 00887868470141: 110029304
• 00887868470134: 110029303
• 00887868470127: 110029302
• 00887868470110: 110029136
• 00887868470103: 110029132
• 00887868470097: 110028923
• 00887868470080: 110028922
• 00887868470073: 110028921
• 00887868470066: 110028920
• 00887868470059: 110028919
• 00887868470042: 110028915
• 00887868504693: 405889
• 00887868504662: 405883
• 00887868504730: 405895
• 00887868504723: 405893
• 00887868504716: 405892
• 00887868504709: 405890
• 00887868504648: 405881
• 00887868504631: 405880