COMPREHENSIVE REVERSE SHOULDER 180578

GUDID 00880304673045

Biomet Orthopedics, LLC

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• Primary Device ID: 00880304673045
• NIH Device Record Key: 80474c93-748b-4528-9562-0b3c215cfd9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COMPREHENSIVE REVERSE SHOULDER
• Version Model Number: 180578
• Catalog Number: 180578
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304673045 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132239

FDA Product Code

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

Sterilization

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

[00880304673045]

Moist Heat or Steam Sterilization

[00880304673045]

Moist Heat or Steam Sterilization

[00880304673045]

Moist Heat or Steam Sterilization

[00880304673045]

Moist Heat or Steam Sterilization

[00880304673045]

Moist Heat or Steam Sterilization

[00880304673045]

Moist Heat or Steam Sterilization

[00880304673045]

Moist Heat or Steam Sterilization

[00880304673045]

Moist Heat or Steam Sterilization

[00880304673045]

Moist Heat or Steam Sterilization

[00880304673045]

Moist Heat or Steam Sterilization

[00880304673045]

Moist Heat or Steam Sterilization

[00880304673045]

Moist Heat or Steam Sterilization

[00880304673045]

Moist Heat or Steam Sterilization

[00880304673045]

Moist Heat or Steam Sterilization

[00880304673045]

Moist Heat or Steam Sterilization

[00880304673045]

Moist Heat or Steam Sterilization

[00880304673045]

Moist Heat or Steam Sterilization

[00880304673045]

Moist Heat or Steam Sterilization

[00880304673045]

Moist Heat or Steam Sterilization

[00880304673045]

Moist Heat or Steam Sterilization

[00880304673045]

Moist Heat or Steam Sterilization

[00880304673045]

Moist Heat or Steam Sterilization

[00880304673045]

Moist Heat or Steam Sterilization

[00880304673045]

Moist Heat or Steam Sterilization

[00880304673045]

Moist Heat or Steam Sterilization

[00880304673045]

Moist Heat or Steam Sterilization

[00880304673045]

Moist Heat or Steam Sterilization

[00880304673045]

Moist Heat or Steam Sterilization

[00880304673045]

Moist Heat or Steam Sterilization

[00880304673045]

Moist Heat or Steam Sterilization

[00880304673045]

Moist Heat or Steam Sterilization

[00880304673045]

Moist Heat or Steam Sterilization

[00880304673045]

Moist Heat or Steam Sterilization

[00880304673045]

Moist Heat or Steam Sterilization

[00880304673045]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-08-09
• Device Publish Date: 2016-10-28

On-Brand Devices [COMPREHENSIVE REVERSE SHOULDER]

• 00880304848481: SSI001948
• 00880304848474: SSI002420
• 00880304848467: SSI002419
• 00880304848450: SSI002418
• 00880304848443: SSI002417
• 00880304848436: SSI003683
• 00880304848429: SSI003682
• 00880304848412: SSI003681
• 00880304848405: SSI003680
• 00880304848399: SSI003679
• 00880304848382: SSI003678
• 00880304848375: SSI003677
• 00880304848368: SSI003676
• 00880304848245: SSI003355
• 00880304687622: TI-115326
• 00880304687615: TI-115323
• 00880304687608: TI-115320
• 00880304687592: TI-115316
• 00880304687585: TI-115313
• 00880304687578: TI-115310
• 00880304681309: 115368
• 00880304681293: 115365
• 00880304681286: 115360
• 00880304677296: 180562
• 00880304677289: 180561
• 00880304677272: 180560
• 00880304677265: 115393
• 00880304677258: 115392
• 00880304677241: 115391
• 00880304677234: 115390
• 00880304677227: 115389
• 00880304677210: 115388
• 00880304677203: 115387
• 00880304677197: 180556
• 00880304677180: 180555
• 00880304677173: 180554
• 00880304677166: 180553
• 00880304677159: 180552
• 00880304677142: 180551
• 00880304677135: 180550
• 00880304677128: 115400
• 00880304677111: 115399
• 00880304677104: 115398
• 00880304677098: 115397
• 00880304677081: 115396
• 00880304677074: 115395
• 00880304677067: 115394
• 00880304673045: 180578
• 00880304568679: 110010424
• 00880304555440: 180563