CautionWear Iron Grip

GUDID 00850836007212

Male Latex Condom, Parallel-Sided, Smooth Surface, Snugger Fit (49 mm), Lubricated With Silicon-Based Lubricant, Non-Spermicidal, Single Foil Pocket.

CAUTION WEAR CORP

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Primary Device ID00850836007212
NIH Device Record Key1e4c98fc-bb8a-4ce9-bfc2-ec299272c612
Commercial Distribution StatusIn Commercial Distribution
Brand NameCautionWear Iron Grip
Version Model NumberCW0001IG
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 100 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100850836007212 [Primary]
GS100850836007229 [Package]
Package: Inner Pack [1000 Units]
In Commercial Distribution
GS100850836007236 [Package]
Contains: 00850836007229
Package: Case [4 Units]
In Commercial Distribution
GS100850836007243 [Package]
Package: Case [4000 Units]
In Commercial Distribution
GS100850836007601 [Package]
Package: Plastic Bag [48 Units]
In Commercial Distribution
GS100850836007618 [Package]
Package: Plastic Bag [100 Units]
In Commercial Distribution
GS100850836007625 [Package]
Package: Plastic Bag [200 Units]
In Commercial Distribution
GS100850836007632 [Package]
Package: Case [500 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 Date2016-09-03

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 Grip2018-07-06Male Latex Condom, Parallel-Sided, Smooth Surface, Snugger Fit (49 mm), Lubricated With Silicon-Based Lubricant, Non-Spermicidal, Single Foil Pocket.
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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