Bigliani/Flatow® Trabecular Metal™ 00-4307-035-46

GUDID 00889024266681

Zimmer, Inc.

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 00889024266681
• NIH Device Record Key: 9d93ddbf-c5eb-4c8e-9c54-389b780b1554
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bigliani/Flatow® Trabecular Metal™
• Version Model Number: 4307-35-46
• Catalog Number: 00-4307-035-46
• 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
• 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 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	00889024266681 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103404

FDA Product Code

• HSD: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Sterilization

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

[00889024266681]

Moist Heat or Steam Sterilization

[00889024266681]

Moist Heat or Steam Sterilization

[00889024266681]

Moist Heat or Steam Sterilization

[00889024266681]

Moist Heat or Steam Sterilization

[00889024266681]

Moist Heat or Steam Sterilization

[00889024266681]

Moist Heat or Steam Sterilization

[00889024266681]

Moist Heat or Steam Sterilization

[00889024266681]

Moist Heat or Steam Sterilization

[00889024266681]

Moist Heat or Steam Sterilization

[00889024266681]

Moist Heat or Steam Sterilization

[00889024266681]

Moist Heat or Steam Sterilization

[00889024266681]

Moist Heat or Steam Sterilization

[00889024266681]

Moist Heat or Steam Sterilization

[00889024266681]

Moist Heat or Steam Sterilization

[00889024266681]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-10-09
• Device Publish Date: 2016-07-28

On-Brand Devices [Bigliani/Flatow® Trabecular Metal™]

• 00889024274266: 47-4307-61
• 00889024274242: 47-4307-31
• 00889024268586: 00-4327-052-56
• 00889024268579: 00-4327-052-46
• 00889024268562: 00-4327-052-00
• 00889024268555: 00-4327-046-52
• 00889024268548: 00-4327-046-40
• 00889024268531: 00-4327-046-00
• 00889024268524: 00-4327-044-00
• 00889024268517: 00-4327-040-46
• 00889024268500: 00-4327-040-00
• 00889024268494: 00-4327-032-52
• 00889024268487: 00-4327-032-46
• 00889024268470: 00-4327-032-40
• 00889024266797: 4307-74
• 00889024266759: 4307-64
• 00889024266742: 4307-63
• 00889024266735: 4307-62
• 00889024266728: 4307-43
• 00889024266711: 4307-42
• 00889024266704: 4307-38
• 00889024266698: 4307-35-52
• 00889024266681: 4307-35-46
• 00889024266674: 4307-35-40
• 00889024266667: 4307-33
• 00889024266650: 4307-32-52
• 00889024266643: 4307-32-46
• 00889024266636: 4307-32-40
• 00889024265585: 00-4301-098-50
• 00889024274259: 47-4307-41