Positioning Wedges SYK41-344-11

GUDID 10850013699398

Body Aligner Wedge 21" X 11.5" x 8">2"

GENEVA HEALTHCARE, LLC

Freestanding patient positioner, single-use

• Primary Device ID: 10850013699398
• NIH Device Record Key: d29b1cb1-0f5d-4077-838e-7a1f0a7bb3f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Positioning Wedges
• Version Model Number: SYK41-344-11
• Catalog Number: SYK41-344-11
• 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	00850013699391 [Package]; Package: case [6 Units]; In Commercial Distribution
GS1	10850013699398 [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: 2019-12-11
• Device Publish Date: 2019-12-03

On-Brand Devices [Positioning Wedges]

• 10850013699398: Body Aligner Wedge 21" X 11.5" x 8">2"
• 10850013699381: 45 Degree Positioning Wedge 23" X 11" X 11"
• 10850013699374: 45 Degree Positioning Wedge 24" X 24" X 12.5"
• 10850013699305: 30 Degree / 60 Degree Positioning Wedge 21" X 11" X 8"
• 10850013699299: 45 Degree Positioning Wedge 18" X 7.5" X 7.5"
• 00810044960396: Body Aligner Wedge 21" X 11.5" x 8">2"
• 00810044960389: 45 Degree Positioning Wedge 23" X 11" X 11"
• 00810044960372: 45 Degree Positioning Wedge 24" X 24" X 12.5"
• 00810044960303: 30 Degree / 60 Degree Positioning Wedge 21" X 11" X 8"
• 00810044960297: 45 Degree Positioning Wedge 18" X 7.5" X 7.5"
• 00810044960549: 45 Degree Positioning Wedge, Pediatric 12" X 7.5" X 3.5"