SKYN

Basic Information

• Brand Name: SKYN
• Primary DI: 00070907229811
• Version / Model: 2981
• Company Name: SURETEX LIMITED - BRANCH
• Labeler DUNS: 672044515
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 36
• Record Status: Published
• Publish Date: 2018-12-20
• Public Version: 4
• Public Version Date: 2023-07-07
• Public Version Status: Update
• Public Device Record Key: 8d257089-5a59-4051-9807-a28a67b528dd

Device Description

SKYN ELITE 36CT

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
Package	30070907229812	GS1	case	6	In Commercial Distribution
Package	10070907229818	GS1	inner	4	In Commercial Distribution
Primary	00070907229811	GS1
Unit of Use	80070907695681	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K171172	000