Comprehensive® 110031434

GUDID 00887868231674

Zimmer, Inc.

Reverse shoulder cup prosthesis trial

• Primary Device ID: 00887868231674
• NIH Device Record Key: c8e71e19-aa11-4dea-a6fc-8c9bec3504f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Comprehensive®
• Version Model Number: 110031434
• Catalog Number: 110031434
• Company DUNS: 056038268
• Company Name: Zimmer, Inc.
• 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)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@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 Identifiers

Device Issuing Agency	Device ID
GS1	00887868231674 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181611

FDA Product Code

• PAO: prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented

Sterilization

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

[00887868231674]

Moist Heat or Steam Sterilization

[00887868231674]

Moist Heat or Steam Sterilization

[00887868231674]

Moist Heat or Steam Sterilization

[00887868231674]

Moist Heat or Steam Sterilization

[00887868231674]

Moist Heat or Steam Sterilization

[00887868231674]

Moist Heat or Steam Sterilization

[00887868231674]

Moist Heat or Steam Sterilization

[00887868231674]

Moist Heat or Steam Sterilization

[00887868231674]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-11
• Device Publish Date: 2019-02-22

On-Brand Devices [Comprehensive®]

• 00887868249174: 110031448
• 00887868244629: 110031451
• 00887868244612: 110031450
• 00887868231780: 110031446
• 00887868231773: 110031445
• 00887868231766: 110031444
• 00887868231759: 110031443
• 00887868231742: 110031442
• 00887868231735: 110031441
• 00887868231728: 110031439
• 00887868231711: 110031438
• 00887868231704: 110031437
• 00887868231698: 110031436
• 00887868231681: 110031435
• 00887868231674: 110031434
• 00887868231667: 110031433
• 00887868231650: 110031432
• 00887868231643: 110031431
• 00887868231483: 110031416
• 00887868231476: 110031415
• 00887868231469: 110031414
• 00887868231452: 110031413
• 00887868231445: 110031412
• 00887868231438: 110031411
• 00887868231421: 110031410
• 00887868231414: 110031409
• 00887868231407: 110031408
• 00887868231391: 110031407
• 00887868231384: 110031406
• 00887868231377: 110031405
• 00887868231360: 110031404
• 00887868231353: 110031403
• 00887868231346: 110031402
• 00887868231339: 110031401
• 00887868231322: 110031400
• 00887868231315: 110031399