ROSA® Shoulder 20808710003

GUDID 00887868557897

Orthosoft Inc

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• Primary Device ID: 00887868557897
• NIH Device Record Key: f8d58e78-6e57-49c2-99f7-15f295747539
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROSA® Shoulder
• Version Model Number: 20-8087-100-03
• Catalog Number: 20808710003
• Company DUNS: 205670032
• Company Name: Orthosoft 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(866)336-7846
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(866)336-7846
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(866)336-7846
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(866)336-7846
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(866)336-7846
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(866)336-7846
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(866)336-7846
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(866)336-7846
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(866)336-7846
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(866)336-7846
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(866)336-7846
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(866)336-7846
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(866)336-7846
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(866)336-7846
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(866)336-7846
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(866)336-7846
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(866)336-7846
• Email: zimmer.consumerrelations@zimmerbiomet.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868557897 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233199

FDA Product Code

• LLZ: System, image processing, radiological

Sterilization

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

[00887868557897]

Moist Heat or Steam Sterilization

[00887868557897]

Moist Heat or Steam Sterilization

[00887868557897]

Moist Heat or Steam Sterilization

[00887868557897]

Moist Heat or Steam Sterilization

[00887868557897]

Moist Heat or Steam Sterilization

[00887868557897]

Moist Heat or Steam Sterilization

[00887868557897]

Moist Heat or Steam Sterilization

[00887868557897]

Moist Heat or Steam Sterilization

[00887868557897]

Moist Heat or Steam Sterilization

[00887868557897]

Moist Heat or Steam Sterilization

[00887868557897]

Moist Heat or Steam Sterilization

[00887868557897]

Moist Heat or Steam Sterilization

[00887868557897]

Moist Heat or Steam Sterilization

[00887868557897]

Moist Heat or Steam Sterilization

[00887868557897]

Moist Heat or Steam Sterilization

[00887868557897]

Moist Heat or Steam Sterilization

[00887868557897]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-14
• Device Publish Date: 2024-03-06

On-Brand Devices [ROSA® Shoulder]

• 00887868580963: 20-8087-506-00
• 00887868575181: 20-8087-134-00
• 00887868575174: 20-8087-133-00
• 00887868575167: 20-8087-132-00
• 00887868575150: 20-8087-131-00
• 00887868575143: 20-8087-130-00
• 00887868575136: 20-8087-129-00
• 00887868575129: 20-8087-128-00
• 00887868575112: 20-8087-127-00
• 00887868575105: 20-8087-126-00
• 00887868558306: 20-8087-700-00
• 00887868558290: 20-8087-503-00
• 00887868558283: 20-8087-501-00
• 00887868558252: 20-8087-504-00
• 00887868558245: ROSAR23021
• 00887868558238: 20-8087-900-00
• 00887868558221: 20-8087-604-00
• 00887868558214: 20-8087-603-00
• 00887868558207: 20-8087-602-00
• 00887868558191: 20-8087-601-00
• 00887868558184: 20-8087-600-00
• 00887868558177: 20-8087-402-00
• 00887868558160: 20-8087-401-00
• 00887868558153: 20-8087-400-00
• 00887868558146: 20-8087-302-00
• 00887868558139: 20-8087-301-00
• 00887868558122: 20-8087-300-00
• 00887868558115: 20-8087-201-00
• 00887868558108: 20-8087-200-00
• 00887868558092: 20-8087-125-00
• 00887868558078: 20-8087-123-00
• 00887868557910: 20-8087-102-00
• 00887868557903: 20-8087-101-00
• 00887868557897: 20-8087-100-03
• 00887868557880: 20-8087-100-02
• 00887868557873: 20-8087-100-01