Dong! 11406

GUDID 20085004341193

Latex Condom 3-ct

MAYER LABORATORIES, INC.

Basic male condom, Hevea-latex

Primary Device ID	20085004341193
NIH Device Record Key	6cf17935-024f-4a7e-aab6-77a16fc28410
Commercial Distribution Status	In Commercial Distribution
Brand Name	Dong!
Version Model Number	Dong! Latex Condoms
Catalog Number	11406
Company DUNS	175425982
Company Name	MAYER LABORATORIES, INC.
Device Count	3
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	true
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	true

Customer Support Contacts

Phone	+1(510)229-5300
Email	davidm@mayerlabs.com
Phone	+1(510)229-5300
Email	davidm@mayerlabs.com
Phone	+1(510)229-5300
Email	davidm@mayerlabs.com
Phone	+1(510)229-5300
Email	davidm@mayerlabs.com
Phone	+1(510)229-5300
Email	davidm@mayerlabs.com
Phone	+1(510)229-5300
Email	davidm@mayerlabs.com
Phone	+1(510)229-5300
Email	davidm@mayerlabs.com
Phone	+1(510)229-5300
Email	davidm@mayerlabs.com
Phone	+1(510)229-5300
Email	davidm@mayerlabs.com
Phone	+1(510)229-5300
Email	davidm@mayerlabs.com
Phone	+1(510)229-5300
Email	davidm@mayerlabs.com
Phone	+1(510)229-5300
Email	davidm@mayerlabs.com
Phone	+1(510)229-5300
Email	davidm@mayerlabs.com
Phone	+1(510)229-5300
Email	davidm@mayerlabs.com
Phone	+1(510)229-5300
Email	davidm@mayerlabs.com
Phone	+1(510)229-5300
Email	davidm@mayerlabs.com
Phone	+1(510)229-5300
Email	davidm@mayerlabs.com

Device Dimensions

Length	160 Millimeter
Width	53 Millimeter
Length	160 Millimeter
Width	53 Millimeter
Length	160 Millimeter
Width	53 Millimeter
Length	160 Millimeter
Width	53 Millimeter
Length	160 Millimeter
Width	53 Millimeter
Length	160 Millimeter
Width	53 Millimeter
Length	160 Millimeter
Width	53 Millimeter
Length	160 Millimeter
Width	53 Millimeter
Length	160 Millimeter
Width	53 Millimeter
Length	160 Millimeter
Width	53 Millimeter
Length	160 Millimeter
Width	53 Millimeter
Length	160 Millimeter
Width	53 Millimeter
Length	160 Millimeter
Width	53 Millimeter
Length	160 Millimeter
Width	53 Millimeter
Length	160 Millimeter
Width	53 Millimeter
Length	160 Millimeter
Width	53 Millimeter
Length	160 Millimeter
Width	53 Millimeter

Operating and Storage Conditions

Storage Environment Temperature	Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
Storage Environment Temperature	Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT

Device Identifiers

Device Issuing Agency	Device ID
GS1	00085004341199 [Primary]
GS1	10085004341196 [Package] Package: MASTER CARTON [8 Units] In Commercial Distribution
GS1	20085004341193 [Package] Contains: 00085004341199 Package: FOLDED CARTON [6 Units] In Commercial Distribution
GS1	30085004341190 [Unit of Use]

FDA Product Code

HIS

CONDOM

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	2023-11-13
Device Publish Date	2023-11-03

On-Brand Devices [Dong!]

20085004341261	Latex Condom 12-ct
20085004341193	Latex Condom 3-ct
20085004340035	Personal Lubricant 4 fl. oz.