Dong! 11407

GUDID 20085004341261

Latex Condom 12-ct

MAYER LABORATORIES, INC.

Basic male condom, Hevea-latex
Primary Device ID20085004341261
NIH Device Record Key472d25a2-d117-42ce-99b6-494723f416d3
Commercial Distribution StatusIn Commercial Distribution
Brand NameDong!
Version Model NumberDong! Latex Condoms
Catalog Number11407
Company DUNS175425982
Company NameMAYER LABORATORIES, INC.
Device Count12
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

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

Device Dimensions

Width53 Millimeter
Length160 Millimeter
Width53 Millimeter
Length160 Millimeter
Width53 Millimeter
Length160 Millimeter
Width53 Millimeter
Length160 Millimeter
Width53 Millimeter
Length160 Millimeter
Width53 Millimeter
Length160 Millimeter
Width53 Millimeter
Length160 Millimeter
Width53 Millimeter
Length160 Millimeter
Width53 Millimeter
Length160 Millimeter
Width53 Millimeter
Length160 Millimeter
Width53 Millimeter
Length160 Millimeter
Width53 Millimeter
Length160 Millimeter
Width53 Millimeter
Length160 Millimeter
Width53 Millimeter
Length160 Millimeter
Width53 Millimeter
Length160 Millimeter
Width53 Millimeter
Length160 Millimeter
Width53 Millimeter
Length160 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100085004341267 [Primary]
GS110085004341264 [Package]
Package: MASTER CARTON [8 Units]
In Commercial Distribution
GS120085004341261 [Package]
Contains: 00085004341267
Package: FOLDED CARTON [6 Units]
In Commercial Distribution
GS130085004341268 [Unit of Use]

FDA Product Code

HISCONDOM

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-13
Device Publish Date2023-11-03

On-Brand Devices [Dong!]

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

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