N/A

GUDID 00889024169777

Zimmer, Inc.

Femoral head bipolar component Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty

• Primary Device ID: 00889024169777
• NIH Device Record Key: 3db561b1-cb8c-4094-b4b6-96479f19a5fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: 4404-22-042
• 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: 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@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

• Lumen/Inner Diameter: 22 Millimeter
• Outer Diameter: 42 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Outer Diameter: 42 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Outer Diameter: 42 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Outer Diameter: 42 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Outer Diameter: 42 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Outer Diameter: 42 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Outer Diameter: 42 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Outer Diameter: 42 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Outer Diameter: 42 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Outer Diameter: 42 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Outer Diameter: 42 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Outer Diameter: 42 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Outer Diameter: 42 Millimeter
• Lumen/Inner Diameter: 22 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024169777 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K833404

FDA Product Code

• KWY: Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-24

On-Brand Devices [N/A]

• 00889024197992: 00-5852-054-19
• 00889024197985: 00-5852-054-18
• 00889024197978: 00-5852-054-17
• 00889024197961: 00-5852-054-16
• 00889024197954: 00-5852-054-15
• 00889024197947: 00-5852-054-14
• 00889024197930: 00-5852-054-13
• 00889024197923: 00-5852-054-12
• 00889024197916: 00-5852-052-19
• 00889024197909: 00-5852-052-18
• 00889024197893: 00-5852-052-17
• 00889024197886: 00-5852-052-16
• 00889024197879: 00-5852-052-15
• 00889024197862: 00-5852-052-14
• 00889024197855: 00-5852-052-13
• 00889024197848: 00-5852-052-12
• 00889024197800: 00-5852-050-19
• 00889024197794: 00-5852-050-18
• 00889024197787: 00-5852-050-17
• 00889024197770: 00-5852-050-16
• 00889024197763: 00-5852-050-15
• 00889024197756: 00-5852-050-14
• 00889024197749: 00-5852-050-13
• 00889024197732: 00-5852-050-12
• 00889024197695: 00-5852-042-17
• 00889024197688: 00-5852-042-09
• 00889024196308: 00-5850-070-13
• 00889024196292: 00-5850-070-12
• 00889024196285: 00-5850-060-26
• 00889024196278: 00-5850-060-23
• 00889024196261: 00-5850-060-20
• 00889024196254: 00-5850-060-17
• 00889024196247: 00-5850-060-14
• 00889024196230: 00-5850-060-12
• 00889024196223: 00-5850-050-26
• 00889024196216: 00-5850-050-23
• 00889024196209: 00-5850-050-20
• 00889024196193: 00-5850-050-17
• 00889024196186: 00-5850-050-14
• 00889024196179: 00-5850-050-12
• 00889024196162: 00-5850-048-20
• 00889024196155: 00-5850-048-09
• 00889024196148: 00-5850-048-08
• 00889024196124: 00-5850-046-45
• 00889024196117: 00-5850-046-35
• 00889024196100: 00-5850-046-22
• 00889024196094: 00-5850-046-20
• 00889024196087: 00-5850-046-18
• 00889024196070: 00-5850-046-16
• 00889024196063: 00-5850-046-14