CautionWear Grande

GUDID 00850836007502

Male Latex Condom, Parallel-Sided, Smooth Texture, Large (56 mm), Lubricated With Silicon-Based Lubricant, Non-Spermicidal, Single Foil Pocket, Unit of Use.

CAUTION WEAR CORP

Basic male condom, Hevea-latex
Primary Device ID00850836007502
NIH Device Record Key979f4710-f25d-4a25-a90a-03850e9e4b7c
Commercial Distribution StatusIn Commercial Distribution
Brand NameCautionWear Grande
Version Model NumberCW0001GR
Company DUNS177056145
Company NameCAUTION WEAR CORP
Device Count1
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 Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone603-598-8500
Emailanatoli@cautionwearcorp.com
Phone603-598-8500
Emailanatoli@cautionwearcorp.com
Phone603-598-8500
Emailanatoli@cautionwearcorp.com
Phone603-598-8500
Emailanatoli@cautionwearcorp.com
Phone603-598-8500
Emailanatoli@cautionwearcorp.com
Phone603-598-8500
Emailanatoli@cautionwearcorp.com
Phone603-598-8500
Emailanatoli@cautionwearcorp.com
Phone603-598-8500
Emailanatoli@cautionwearcorp.com
Phone603-598-8500
Emailanatoli@cautionwearcorp.com
Phone603-598-8500
Emailanatoli@cautionwearcorp.com
Phone603-598-8500
Emailanatoli@cautionwearcorp.com
Phone603-598-8500
Emailanatoli@cautionwearcorp.com
Phone603-598-8500
Emailanatoli@cautionwearcorp.com
Phone603-598-8500
Emailanatoli@cautionwearcorp.com
Phone603-598-8500
Emailanatoli@cautionwearcorp.com
Phone603-598-8500
Emailanatoli@cautionwearcorp.com
Phone603-598-8500
Emailanatoli@cautionwearcorp.com
Phone603-598-8500
Emailanatoli@cautionwearcorp.com
Phone603-598-8500
Emailanatoli@cautionwearcorp.com
Phone603-598-8500
Emailanatoli@cautionwearcorp.com
Phone603-598-8500
Emailanatoli@cautionwearcorp.com
Phone603-598-8500
Emailanatoli@cautionwearcorp.com
Phone603-598-8500
Emailanatoli@cautionwearcorp.com
Phone603-598-8500
Emailanatoli@cautionwearcorp.com
Phone603-598-8500
Emailanatoli@cautionwearcorp.com
Phone603-598-8500
Emailanatoli@cautionwearcorp.com
Phone603-598-8500
Emailanatoli@cautionwearcorp.com
Phone603-598-8500
Emailanatoli@cautionwearcorp.com
Phone603-598-8500
Emailanatoli@cautionwearcorp.com
Phone603-598-8500
Emailanatoli@cautionwearcorp.com
Phone603-598-8500
Emailanatoli@cautionwearcorp.com
Phone603-598-8500
Emailanatoli@cautionwearcorp.com
Phone603-598-8500
Emailanatoli@cautionwearcorp.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 32 Degrees Celsius and 100 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Celsius and 100 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Celsius and 100 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Celsius and 100 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Celsius and 100 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Celsius and 100 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Celsius and 100 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Celsius and 100 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Celsius and 100 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Celsius and 100 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Celsius and 100 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Celsius and 100 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Celsius and 100 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Celsius and 100 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Celsius and 100 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Celsius and 100 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Celsius and 100 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Celsius and 100 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Celsius and 100 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Celsius and 100 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Celsius and 100 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Celsius and 100 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Celsius and 100 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Celsius and 100 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Celsius and 100 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Celsius and 100 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Celsius and 100 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Celsius and 100 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Celsius and 100 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Celsius and 100 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Celsius and 100 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Celsius and 100 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Celsius and 100 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100850836007472 [Primary]
GS100850836007489 [Package]
Contains: 00850836007472
Package: Inner Pack [1000 Units]
In Commercial Distribution
GS100850836007496 [Package]
Contains: 00850836007489
Package: Case [4 Units]
In Commercial Distribution
GS100850836007502 [Package]
Contains: 00850836007472
Package: Case [4000 Units]
In Commercial Distribution
GS100850836007847 [Package]
Contains: 00850836007472
Package: Plastic Bag [24 Units]
In Commercial Distribution
GS100850836007854 [Package]
Contains: 00850836007472
Package: Plastic Bag [50 Units]
In Commercial Distribution
GS100850836007861 [Package]
Contains: 00850836007472
Package: Plastic Bag [100 Units]
In Commercial Distribution
GS100850836007878 [Package]
Contains: 00850836007472
Package: Plastic Bag [200 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HISCondom

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-10-11

Devices Manufactured by CAUTION WEAR CORP

00850836007762 - CautionWear L.A.Confidential - Dark Desire2021-06-29 Male Latex Condom, Contoured, Regular Fit (53 mm), Parallel-Sided, N-9 FREE, Transparent in Color (clear latex), With Reservoir
00850836007724 - CautionWear L.A.Confidential - Silky Touch2021-06-29 Male Latex Condom, Extra Lubricated, Regular Fit (53 mm), Parallel-Sided, N-9 FREE, Transparent in Color (clear latex), With Res
00850836007069 - CautionWear L.A.Confidential - Secret Passion2021-06-28 Male Latex Condom, Studded, Regular Fit (53 mm), Parallel-Sided, N-9 FREE, Transparent in Color (clear latex), With Reservoir Ti
00850836007212 - CautionWear Iron Grip2018-07-06 Male Latex Condom, Parallel-Sided, Smooth Surface, Snugger Fit (49 mm), Lubricated With Silicon-Based Lubricant, Non-Spermicidal
00850836007250 - CautionWear Classic2018-07-06 Male Latex Condom, Parallel-Sided, Smooth Surface, Regular Fit (53mm), Lubricated With Silicon-Based Lubricant, Non-Spermicidal,
00850836007328 - CautionWear Wild Rose2018-07-06 Male Latex Condom, Parallel-Sided, Ribbed Texture, Regular Fit (53 mm), Lubricated With Silicon-Based Lubricant, Non-Spermicidal
00850836007342 - FPA2018-07-06 Male Latex Condom, Parallel-Sided, Smooth Surface, Regular Fit (53 mm), Lubricated With Silicon Based Lubricant, Non-Spermicidal
00850836007373 - CautionWear Black Ice2018-07-06 Male Latex Condom, Parallel-Sided, Smooth Surface, Ultra Thin, Regular Fit (53mm), Lubricated With Silicon-Based Lubricant, Non-

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