FDA.reportPublic FDA data

Union

Primary DI
10054003788592
Brand
Union
Company
MAYER LABORATORIES, INC.
Model
Union Latex Condoms Standard
Catalog number
11401
Device description
Latex Condoms 144 ct
Published
2023-11-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HISCONDOM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HISCondomObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10054003788592PackageGS120In Commercial Distribution
20054003788599PackageGS1144In Commercial Distribution
00054003788595PrimaryGS10
30054003788596Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1005400378859210054003788592
2005400378859920054003788599
00054003788595000540037885950540037885950054003788595
3005400378859630054003788596

GMDN Terms#

Term, Definition table
TermDefinition
Basic male condom, Hevea-latexA Hevea-latex rubber sheath intended to completely cover the penis during coitus to prevent sperm from gaining access to the female reproductive tract and/or prevent the transmission of sexually transmitted infections (STI). It may be textured, flavoured or contain lubricants. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length160Millimeter
Width53Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00NO DIRECT SUNLIGHT OR HEAT
Storage Environment Temperature40 Degrees Fahrenheit90 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
175425982
Device count
144
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00016169010248ThinKimono10242025-10-06
00016169030130MAXX Large FlareKimono MAXX030132025-10-06
00016169050404MicroThinKimono50402025-10-06
00016169070242MicroThin Ribbed + Sensi-DotsKimono70242025-10-06
00016169088032Kimono MicroThin XLKimono Microthin XL Condoms088032025-10-06
00016169114090Callvin RegularCallvin Latex Condom114092025-10-06
00016169114106Callvin GoldCallvin Latex Condom114102025-10-06
00016169114113PlaygroundPlayground Condoms114112025-10-06
00016169700057Nauox Yin YangNauox Yin Yang700052025-10-06
00016169700064Nauox Holy HoneyNauox Holy Honey700062025-10-06
00016169700071Nauox Dulce DreamsNauox Dulce Dreams700072025-10-06
00016169700088Nauox Sweet HavenNauox Sweet Haven700082025-10-06
00016169700095Naoux Agave NectarNaoux Agave Nectar700092025-10-06
00016169700194Femme GlydeFemme Glide Natural Lubriant700192025-10-06
00198715811087Kindra V LubeKindra Silicone Lubricant700182025-10-06
06279870714292NixitNixit Natural Lubricant700042023-11-03
00860004693543Pill ClubPeriod Care Reg Pads999-001-042022-02-09
00860004693550Pill ClubPeriod Care Super Pads999-001-052022-02-09
00860004693567Pill ClubPeriod Care Combo Pads999-001-062022-02-09
00860004693598Pill ClubPeriod Care Combo Tampons&Pads999-001-092022-02-09

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00726893120761Super sensitiveGLOBAL PROTECTION CORP.HIS2026-06-04
20726893120482Mixed PleasureGLOBAL PROTECTION CORP.HIS2026-06-04
20726893120710Glowing PleasuresGLOBAL PROTECTION CORP.HIS2026-06-04
00860013783549CaliberCaliber Brand LLCHIS2026-06-02
00860013783556CaliberCaliber Brand LLCHIS2026-06-02
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