Bigliani/Flatow®

GUDID 00889024264854

Zimmer, Inc.

Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 00889024264854
• NIH Device Record Key: efc5666f-f44b-4063-acc2-a049632e6c43
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bigliani/Flatow®
• Version Model Number: 4301-34-01
• Company DUNS: 056038268
• Company Name: Zimmer, Inc.
• Device Count: 2
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024264854 [Primary]
GS1	00889024466272 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103404

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-04-08
• Device Publish Date: 2016-08-09

On-Brand Devices [Bigliani/Flatow®]

• 00889024455276: 8543-01-02
• 00889024274235: 47-4301-31
• 00889024266780: 00-4307-066-52
• 00889024266773: 00-4307-066-46
• 00889024266766: 00-4307-066-40
• 00889024266629: 00-4307-030-52
• 00889024266612: 00-4307-030-46
• 00889024266605: 00-4307-030-40
• 00889024379695: 4303-75-01
• 00889024266353: 4303-75
• 00889024266261: 4303-54
• 00889024266254: 4303-52-56
• 00889024266247: 4303-52-46
• 00889024266230: 4303-52-33
• 00889024266223: 4303-52-30
• 00889024266216: 4303-52-27
• 00889024266209: 4303-52-24
• 00889024266193: 4303-52-23
• 00889024266186: 4303-52-21
• 00889024266179: 4303-52-19
• 00889024266162: 4303-52-18
• 00889024266155: 4303-46-52
• 00889024266148: 4303-46-40
• 00889024266131: 4303-46-30
• 00889024266124: 4303-46-27
• 00889024266117: 4303-46-24
• 00889024266100: 4303-46-23
• 00889024266094: 4303-46-21
• 00889024266087: 4303-46-19
• 00889024266070: 4303-46-18
• 00889024266063: 4303-46-17
• 00889024266056: 4303-46-15
• 00889024266049: 4303-40-46
• 00889024266032: 4303-40-27
• 00889024266025: 4303-40-24
• 00889024266018: 4303-40-21
• 00889024266001: 4303-40-18
• 00889024265998: 4303-40-15
• 00889024265851: 4302-52-56
• 00889024265844: 4302-52-46
• 00889024265837: 4302-52-33
• 00889024265820: 4302-52-30
• 00889024265813: 4302-52-27
• 00889024265806: 4302-52-24
• 00889024265790: 4302-52-23
• 00889024265783: 4302-52-21
• 00889024265776: 4302-52-19
• 00889024265769: 4302-52-18
• 00889024265752: 4302-46-52
• 00889024265745: 4302-46-40