Neoflex Active CA700-FPA-0

GUDID 00850013242450

Prosthetic suspension sleeve with knee pad reinforcement in grey/black color and size 0

CYPRESS ADAPTIVE, LLC

Prosthesis suspension system External lower-limb prosthesis suspensory component, non-powered External lower-limb prosthesis suspensory component, non-powered External lower-limb prosthesis suspensory component, non-powered External lower-limb prosthesis suspensory component, non-powered External lower-limb prosthesis suspensory component, non-powered External lower-limb prosthesis suspensory component, non-powered External lower-limb prosthesis suspensory component, non-powered External lower-limb prosthesis suspensory component, non-powered

• Primary Device ID: 00850013242450
• NIH Device Record Key: 291a8db9-fb47-41ab-8bf2-19141d6496d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neoflex Active
• Version Model Number: CA700-FPA-0
• Catalog Number: CA700-FPA-0
• Company DUNS: 080277500
• Company Name: CYPRESS ADAPTIVE, 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: false
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850013242450 [Primary]

FDA Product Code

• ISS: Prosthesis, Thigh Socket, External Component

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: 2019-12-17
• Device Publish Date: 2019-12-09

On-Brand Devices [Neoflex Active]

• 00850013242528: Prosthetic suspension sleeve with knee pad reinforcement in grey/black color and size 5.0.
• 00850013242511: Prosthetic suspension sleeve with knee pad reinforcement in grey/black color and size 4.0
• 00850013242504: Prosthetic suspension sleeve with knee pad reinforcement in grey/black color and size 3.0
• 00850013242498: Prosthetic suspension sleeve with knee pad reinforcement in grey/black color and size 2.5
• 00850013242481: Prosthetic suspension sleeve with knee pad reinforcement in grey/black color and size 2.0
• 00850013242474: Prosthetic suspension sleeve with knee pad reinforcement in color gray/black and size 1.5.
• 00850013242467: Prosthetic suspension sleeve with knee pad reinforcement in color gray/black and size 1.0.
• 00850013242450: Prosthetic suspension sleeve with knee pad reinforcement in grey/black color and size 0