FDA.reportPublic FDA data

Eddie

Primary DI
00850013700608
Brand
Eddie
Company
Giddy Holdings, Inc.
Model
EDDIE-21-210-2-R2
Device description
Size A, 2 pack
Published
2026-10-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
false

Product Codes#

Code, Name table
CodeName
LKYDevice, External Penile Rigidity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LKYDevice, External Penile RigidityGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850013700608PrimaryGS10
00850013700660Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850013700608008500137006088500137006080850013700608
00850013700660008500137006608500137006600850013700660

GMDN Terms#

Term, Definition table
TermDefinition
Penile ringA device intended to be applied externally to the penis for the management of erectile dysfunction (ED) (commonly known as impotence) by enabling the maintenance of a penile erection adequate for vaginal intercourse. It is typically designed as a flexible rubber loop that is placed on the penis (i.e., around its base) to restrict the flow of venous blood leaving the penis during an erection. This device can be used alone or with a penile vacuum pump. This is a reusable device.

Regulatory Flags#

DUNS number
023415411
Device count
2
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850013700639EddieEDDIE-22-220-2-R22026-10-05
00850013700646EddieEDDIE-23-230-2-R22026-10-05
00850013700653EddieEDDIE-24-240-2-R22026-10-05
00850013700158EddieEDDIE-11-110-12023-05-09
00850013700165EddieEDDIE-21-210-22023-05-09
00850013700172EddieEDDIE-12-120-12023-05-09
00850013700189EddieEDDIE-22-220-22023-05-09
00850013700196EddieEDDIE-13-130-12023-05-09
00850013700202EddieEDDIE-23-230-22023-05-09
00850013700219EddieEDDIE-14-140-12023-05-09
00850013700226EddieEDDIE-24-240-22023-05-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850013700639EddieGiddy Holdings, Inc.LKY2026-10-05
00850013700646EddieGiddy Holdings, Inc.LKY2026-10-05
00850013700653EddieGiddy Holdings, Inc.LKY2026-10-05
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00850076064013Pump Worx Max Boost - White PD Products, LLCLKY2026-05-01
00850076064020Max Boost Pro Flow - Blue/Clear PD Products, LLCLKY2026-05-01
00850076064037Pipedream Beginner's Power Pump - Black PD Products, LLCLKY2026-05-01
00850076064044Pump Worx Max Boost - Black PD Products, LLCLKY2026-05-01
00850076064051Pipedream Beginner's Power Pump - Blue PD Products, LLCLKY2026-05-01
00850076064068Pump Worx Beginner's Vibrating Pump - Clear/Black PD Products, LLCLKY2026-05-01
00850076064075Max Boost Pro Flow - White/Clear PD Products, LLCLKY2026-05-01
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00850076064129Pump Worx Silicone Power Pump - Clear/Black PD Products, LLCLKY2026-05-01
00850076064136Pump Worx Beginner's Power Pump - Purple PD Products, LLCLKY2026-05-01
00850076064143Pump Worx Beginner's Power Pump - Clear PD Products, LLCLKY2026-05-01
00850076064150Classix Power PumpPD Products, LLCLKY2026-05-01
00850076064167Pump Worx Beginner's Power Pump - Red PD Products, LLCLKY2026-05-01
00850076064174Classix Vibrating Power Pump - ClearPD Products, LLCLKY2026-05-01
00850076064181Pump Worx Beginner's Power Pump - Smoke/Black PD Products, LLCLKY2026-05-01
00850076064198Pump Worx Pistol-Grip Power Pump - Clear/Black PD Products, LLCLKY2026-05-01
00850076064204Pump Worx Max-Width Penis Enlarger - Clear/Black PD Products, LLCLKY2026-05-01
00850076064211Pipedream Beginner's Power Pump - Clear PD Products, LLCLKY2026-05-01
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00850005747284Dr. Joel KaplanDr. Joel Kaplan, Inc.LKY2025-04-14
00850005747291Dr. Joel KaplanDr. Joel Kaplan, Inc.LKY2025-04-14