FDA.report

FUN FACTORY

Primary DI
04032498511009
Brand
FUN FACTORY
Company
FUN FACTORY GmbH
Model
51100
Device description
NOS, black
Published
2021-05-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LKYDevice, External Penile Rigidity

Product Code Classifications

CodeDeviceSpecialtyClass
LKYDevice, External Penile RigidityGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04032498511009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04032498511009040324985110094032498511009

GMDN Terms

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.

Sterilization Methods

Method

Contacts

PhoneEmail
+49421520760info@funfactory.com

Regulatory Flags

DUNS number
314187530
Device count
1
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 DIBrandModelCatalogPublished
04032498511016FUN FACTORY511012021-05-19
04032498950051FUN FACTORY950052021-05-19
04032498950075FUN FACTORY950072021-05-19
04032498950068FUN FACTORY950062021-05-18

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00850005747079Dr. Joel KaplanDr. Joel Kaplan, Inc.LKY2025-04-14
00850005747260Dr. Joel KaplanDr. Joel Kaplan, Inc.LKY2025-04-14
00850005747277Dr. Joel KaplanDr. Joel Kaplan, Inc.LKY2025-04-14
00850005747284Dr. Joel KaplanDr. Joel Kaplan, Inc.LKY2025-04-14
00850005747291Dr. Joel KaplanDr. Joel Kaplan, Inc.LKY2025-04-14
00850005747543Dr. Joel KaplanDr. Joel Kaplan, Inc.LKY2025-04-14
00850005747550Dr. Joel KaplanDr. Joel Kaplan, Inc.LKY2025-04-14
00850005747567Dr. Joel KaplanDr. Joel Kaplan, Inc.LKY2025-04-14
00850005747574Dr. Joel KaplanDr. Joel Kaplan, Inc.LKY2025-04-14
00850002870718Performance PlusBlush NoveltiesLKY2025-03-17
00850002870725Performance PlusBlush NoveltiesLKY2025-03-17
00850002870619Performance PlusBlush NoveltiesLKY2025-02-14
00850002870626Performance PlusBlush NoveltiesLKY2025-02-14
00850002870633Performance PlusBlush NoveltiesLKY2025-02-14
00850002870640Performance PlusBlush NoveltiesLKY2025-02-14
00850002870657Performance PlusBlush NoveltiesLKY2025-02-14
00850002870664Performance PlusBlush NoveltiesLKY2025-02-14
00850002870671Performance PlusBlush NoveltiesLKY2025-02-14
00850002870688Performance PlusBlush NoveltiesLKY2025-02-14
00850002870695Performance PlusBlush NoveltiesLKY2025-02-14
00850002870701Performance PlusBlush NoveltiesLKY2025-02-14
00850002870565Play With MeBlush NoveltiesLKY2024-12-13
00850002870572Play With MeBlush NoveltiesLKY2024-12-13
00850004857113EDP REACH MEDICAL, INC.LKY2024-01-18
05060140201113BathmateDX PRODUCTS LIMITEDLKY2024-01-01
00850004857106EDP MAXRCREACH MEDICAL, INC.LKY2023-12-28
05060140200963VAXAIDDX PRODUCTS LIMITEDLKY2023-10-01
05060140201076BathmateDX PRODUCTS LIMITEDLKY2023-10-01
05060140201083BathmateDX PRODUCTS LIMITEDLKY2023-10-01
05060140201090BathmateDX PRODUCTS LIMITEDLKY2023-10-01