SKYN

Basic Information

• Brand Name: SKYN
• Primary DI: 00070907209394
• Version / Model: 0939
• Company Name: SURETEX LIMITED - BRANCH
• Labeler DUNS: 672044515
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 22
• Record Status: Published
• Publish Date: 2016-07-11
• Public Version: 8
• Public Version Date: 2023-07-07
• Public Version Status: Update
• Public Device Record Key: 3abffeba-8622-4c0e-995f-2a89c989b0ca

Device Description

SKYN EXTRA STUDDED 22CT

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MOL	Condom, Synthetic	Obstetrics/Gynecology	884.5300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34151	Basic male condom, synthetic polymer	A sheath made from synthetic polymers (e.g., polyurethane, polyisoprene) 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	00070907209394	GS1
Unit of Use	80070907695711	GS1
Package	10070907209391	GS1	inner	4	In Commercial Distribution
Package	30070907209395	GS1	case	6	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K171172	000