Bigliani/Flatow® 00-4301-065-00

GUDID 00889024265394

Zimmer, Inc.

Shoulder glenoid fossa prosthesis trial

• Primary Device ID: 00889024265394
• NIH Device Record Key: 0428ce96-3c21-4218-acd1-b8ae3f214c93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bigliani/Flatow®
• Version Model Number: 4301-65
• Catalog Number: 00-4301-065-00
• 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
• 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 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	00889024265394 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103404

FDA Product Code

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

Sterilization

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

[00889024265394]

Moist Heat or Steam Sterilization

[00889024265394]

Moist Heat or Steam Sterilization

[00889024265394]

Moist Heat or Steam Sterilization

[00889024265394]

Moist Heat or Steam Sterilization

[00889024265394]

Moist Heat or Steam Sterilization

[00889024265394]

Moist Heat or Steam Sterilization

[00889024265394]

Moist Heat or Steam Sterilization

[00889024265394]

Moist Heat or Steam Sterilization

[00889024265394]

Moist Heat or Steam Sterilization

[00889024265394]

Moist Heat or Steam Sterilization

[00889024265394]

Moist Heat or Steam Sterilization

[00889024265394]

Moist Heat or Steam Sterilization

[00889024265394]

Moist Heat or Steam Sterilization

[00889024265394]

Moist Heat or Steam Sterilization

[00889024265394]

Moist Heat or Steam Sterilization

[00889024265394]

Moist Heat or Steam Sterilization

[00889024265394]

Moist Heat or Steam Sterilization

[00889024265394]

Moist Heat or Steam Sterilization

[00889024265394]

Moist Heat or Steam Sterilization

[00889024265394]

Moist Heat or Steam Sterilization

[00889024265394]

Moist Heat or Steam Sterilization

[00889024265394]

Moist Heat or Steam Sterilization

[00889024265394]

Moist Heat or Steam Sterilization

[00889024265394]

Moist Heat or Steam Sterilization

[00889024265394]

Moist Heat or Steam Sterilization

[00889024265394]

Moist Heat or Steam Sterilization

[00889024265394]

Moist Heat or Steam Sterilization

[00889024265394]

Moist Heat or Steam Sterilization

[00889024265394]

Moist Heat or Steam Sterilization

[00889024265394]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2019-10-09
• Device Publish Date: 2016-07-15

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