Anatomical Shoulder™ Bigliani/Flatow®

GUDID 00889024287990

AS B/F Silhouette 45°

Zimmer GmbH

Joint prosthesis implantation kit, reusable

• Primary Device ID: 00889024287990
• NIH Device Record Key: 6a0a088f-093c-4112-a9a1-00ce2ce23f5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anatomical Shoulder™ Bigliani/Flatow®
• Version Model Number: 01.04255.245
• Company DUNS: 488133448
• Company Name: Zimmer GmbH
• 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: true
• 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)348-2759
• Email: zimmer.consumerrelations@zimmer.com

Device Dimensions

• Angle: 45 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024287990 [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

[00889024287990]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-10-14
• Device Publish Date: 2015-10-23

On-Brand Devices [Anatomical Shoulder™ Bigliani/Flatow®]

• 00889024485778: AS B/F Resection guide 48°
• 00889024485761: AS B/F Resection guide 45°
• 00889024485754: AS B/F Resection guide 42°
• 00889024485747: AS B/F Silhouette 45°
• 00889024485730: AS B/F Cutting guide 45°
• 00889024485723: AS B/F Extractor Instrument for Adaptor
• 00889024485716: AS B/F Provisional Adaptor 48°
• 00889024485709: AS B/F Provisional Adaptor 45°
• 00889024485693: AS B/F Provisional Adaptor 42°
• 00889024288027: AS B/F Resection guide 48°
• 00889024288010: AS B/F Resection guide 45°
• 00889024288003: AS B/F Resection guide 42°
• 00889024287990: AS B/F Silhouette 45°
• 00889024287983: AS B/F Cutting guide 45°
• 00889024287976: AS B/F Extractor Instrument for Adaptor
• 00889024287969: AS B/F Provisional Adaptor 48°
• 00889024287952: AS B/F Provisional Adaptor 45°
• 00889024287945: AS B/F Provisional Adaptor 42°
• 10889024287898: 01.04255.000