BiPolar Hip System

GUDID 10840843102533

Stelkast Incorporated

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 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: 10840843102533
• NIH Device Record Key: 8f6cc1fe-cf23-481b-9994-cb196a67f573
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BiPolar Hip System
• Version Model Number: SC1866-54/28
• Company DUNS: 804792265
• Company Name: Stelkast Incorporated
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840843102533 [Primary]

FDA Product Code

• KWL: Prosthesis, Hip, Hemi-, Femoral, Metal

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: 2020-09-09
• Device Publish Date: 2014-12-29

On-Brand Devices [BiPolar Hip System]

• 10840843102649: SC1866-65/28
• 10840843102632: SC1866-64/28
• 10840843102625: SC1866-63/28
• 10840843102618: SC1866-62/28
• 10840843102601: SC1866-61/28
• 10840843102595: SC1866-60/28
• 10840843102588: SC1866-59/28
• 10840843102571: SC1866-58/28
• 10840843102564: SC1866-57/28
• 10840843102557: SC1866-56/28
• 10840843102540: SC1866-55/28
• 10840843102533: SC1866-54/28
• 10840843102526: SC1866-53/28
• 10840843102519: SC1866-52/28
• 10840843102502: SC1866-51/28
• 10840843102496: SC1866-50/28
• 10840843102489: SC1866-49/28
• 10840843102472: SC1866-48/28
• 10840843102465: SC1866-47/28
• 10840843102458: SC1866-46/28
• 10840843102441: SC1866-45/28
• 10840843102434: SC1866-44/22
• 10840843102427: SC1866-43/22
• 10840843102410: SC1866-42/22
• 10840843102403: SC1866-41/22
• 10840843102397: SC1866-40/22
• 10840843102380: SC1866-39/22