Union 11405

GUDID 20054003788605

Latex Condoms 144 ct

MAYER LABORATORIES, INC.

Basic male condom, Hevea-latex
Primary Device ID20054003788605
NIH Device Record Keyd623123c-0604-48a1-bd3c-bae95d466069
Commercial Distribution StatusIn Commercial Distribution
Brand NameUnion
Version Model NumberUnion Latex Condoms Snug Fit
Catalog Number11405
Company DUNS175425982
Company NameMAYER LABORATORIES, INC.
Device Count144
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

Width49 Millimeter
Length160 Millimeter
Width49 Millimeter
Length160 Millimeter
Width49 Millimeter
Length160 Millimeter
Width49 Millimeter
Length160 Millimeter
Width49 Millimeter
Length160 Millimeter
Width49 Millimeter
Length160 Millimeter
Width49 Millimeter
Length160 Millimeter
Width49 Millimeter
Length160 Millimeter
Width49 Millimeter
Length160 Millimeter
Width49 Millimeter
Length160 Millimeter
Width49 Millimeter
Length160 Millimeter
Width49 Millimeter
Length160 Millimeter
Width49 Millimeter
Length160 Millimeter
Width49 Millimeter
Length160 Millimeter
Width49 Millimeter
Length160 Millimeter
Width49 Millimeter
Length160 Millimeter
Width49 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
GS100054003788601 [Primary]
GS110054003788608 [Package]
Package: MASTER CARTON [20 Units]
In Commercial Distribution
GS120054003788605 [Package]
Contains: 00054003788601
Package: CARTON [144 Units]
In Commercial Distribution
GS130054003788602 [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 Date2023-11-14
Device Publish Date2023-11-06

On-Brand Devices [Union]

20054003788605Latex Condoms 144 ct
10054003788592Latex Condoms 144 ct
10054003788585Latex Condoms 144 ct

Trademark Results [Union]

Mark Image

Registration | Serial
Company
Trademark
Application Date
UNION
UNION
97899379 not registered Live/Pending
THE HUMAN UNION, LLC
2023-04-20
UNION
UNION
97899379 not registered Live/Pending
Smeltzer, Michael
2023-04-20
UNION
UNION
97873897 not registered Live/Pending
Union Uhrenfabrik GmbH
2023-04-05
UNION
UNION
97863500 not registered Live/Pending
The Union LLC
2023-03-29
UNION
UNION
97862800 not registered Live/Pending
The Union LLC
2023-03-29
UNION
UNION
97730181 not registered Live/Pending
Union Uhrenfabrik GmbH
2022-12-23
UNION
UNION
97697560 not registered Live/Pending
WireCo WorldGroup Inc.
2022-11-30
UNION
UNION
97569173 not registered Live/Pending
Union Credit Inc.
2022-08-29
UNION
UNION
97432208 not registered Live/Pending
Pool Data Ltd
2022-05-27
UNION
UNION
97379136 not registered Live/Pending
Major League Soccer, L.L.C.
2022-04-25
UNION
UNION
90832644 not registered Live/Pending
Monterey Bay Football Club LLC
2021-07-16
UNION
UNION
90531550 not registered Live/Pending
Nuclyde Inc.
2021-02-17

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.