Arthroscopic Positioners SYK41-226-11

GUDID 10850013699206

Well Leg Holder 32" X 10" X 5"

GENEVA HEALTHCARE, LLC

Freestanding patient positioner, single-use

• Primary Device ID: 10850013699206
• NIH Device Record Key: 41a547bc-882f-45e9-b18b-270e7ef6aac0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Arthroscopic Positioners
• Version Model Number: SYK41-226-11
• Catalog Number: SYK41-226-11
• Company DUNS: 964459106
• Company Name: GENEVA HEALTHCARE, LLC
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-262-767-9870
• Email: info@genevahc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850013699209 [Package]; Package: case [4 Units]; In Commercial Distribution
GS1	10850013699206 [Primary]

FDA Product Code

• CCX: Support, Patient Position

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-10
• Device Publish Date: 2019-12-02

On-Brand Devices [Arthroscopic Positioners]

• 10850013699206: Well Leg Holder 32" X 10" X 5"
• 00810044960204: Well Leg Holder 32" X 10" X 5"
• 00810044961263: Well Leg Holder 32" X 10" X 5"- 30-115-00 - 10810044960201 Knee Holder 11.5" x 10.5" x 3" - 30-1
• 10810044961253: Knee Holder 11.5" x 10.5" x 3"