Eddie

GUDID 00850013700158

Giddy Holdings, Inc.

Penile ring

• Primary Device ID: 00850013700158
• NIH Device Record Key: bb464c05-6102-40de-aaee-8606ab6fedb8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eddie
• Version Model Number: EDDIE-11-110-1
• Company DUNS: 023415411
• Company Name: Giddy Holdings, Inc.
• 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: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850013700158 [Primary]

FDA Product Code

• LKY: Device, External Penile Rigidity

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-17
• Device Publish Date: 2023-05-09

On-Brand Devices [Eddie]

• 00850013700226: EDDIE-24-240-2
• 00850013700219: EDDIE-14-140-1
• 00850013700202: EDDIE-23-230-2
• 00850013700196: EDDIE-13-130-1
• 00850013700189: EDDIE-22-220-2
• 00850013700172: EDDIE-12-120-1
• 00850013700165: EDDIE-21-210-2
• 00850013700158: EDDIE-11-110-1