Glide

GUDID 00850004850886

Glide Fabrication kit with 8 dummies

INFINITE BIOMEDICAL TECHNOLOGIES, LLC

Myoelectric hand prosthesis

• Primary Device ID: 00850004850886
• NIH Device Record Key: e1e9d3b9-fc00-4f89-afd4-618b699b7536
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Glide
• Version Model Number: 94001-8
• Company DUNS: 037376022
• Company Name: INFINITE BIOMEDICAL TECHNOLOGIES, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850004850886 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240884

FDA Product Code

• GXY: Electrode, Cutaneous

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: 2025-03-28
• Device Publish Date: 2025-03-20

On-Brand Devices [Glide]

• 00850004850619: Glide
• 00850004850855: IBT Remote Dome Electrode - Gray
• 00850004850848: IBT Remote Dome Electrode - Brown
• 00850004850831: IBT Remote Dome Electrode - Purple
• 00850004850824: IBT Remote Dome Electrode - Orange
• 00850004850817: IBT Remote Dome Electrode - Green
• 00850004850800: IBT Remote Dome Electrode - Blue
• 00850004850794: IBT Remote Dome Electrode - Red
• 00850004850787: IBT Remote Dome Electrode - Black
• 00850004850770: Core2 Controller - GL
• 00850004850763: Dome Fabrication Kit - ST
• 00850004850756: Core2 Fabrication Kit
• 00850004850749: Glide
• 00850004850732: Glide
• 00850004850725: Glide
• 00850004850718: Glide
• 00850004850701: Glide
• 00850004850695: Glide
• 00850004850688: Glide
• 00850004850671: Glide
• 00850004850664: Glide
• 00850004850657: Glide
• 00850004850640: Glide
• 00850004850633: Glide
• 00850004850626: Glide
• 00850004850886: Glide Fabrication kit with 8 dummies
• 00850004850879: Glide Fabrication kit with 4 dummies