CautionWear Iron Grip

Basic Information

• Brand Name: CautionWear Iron Grip
• Primary DI: 00850836007212
• Version / Model: CW0001IG
• Company Name: CAUTION WEAR CORP
• Labeler DUNS: 177056145
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-03
• Public Version: 4
• Public Version Date: 2021-06-17
• Public Version Status: Update
• Public Device Record Key: 1e4c98fc-bb8a-4ce9-bfc2-ec299272c612

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HIS	Condom	Obstetrics/Gynecology	884.5300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45138	Basic male condom, Hevea-latex	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850836007212	GS1
Package	00850836007243	GS1	Case	4000	In Commercial Distribution
Package	00850836007229	GS1	Inner Pack	1000	In Commercial Distribution
Package	00850836007236	GS1	Case	4	In Commercial Distribution
Package	00850836007601	GS1	Plastic Bag	48	In Commercial Distribution
Package	00850836007618	GS1	Plastic Bag	100	In Commercial Distribution
Package	00850836007625	GS1	Plastic Bag	200	In Commercial Distribution
Package	00850836007632	GS1	Case	500	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K002393	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 32 – 100 Degrees Fahrenheit