SKYN

GUDID 80070907324451

SKYN LARGE STPS 1000s

SURETEX LIMITED - BRANCH

Basic male condom, synthetic polymer

• Primary Device ID: 80070907324451
• NIH Device Record Key: a492f561-428f-4964-b5f8-6506ca863fa2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SKYN
• Version Model Number: 7400
• Company DUNS: 672044515
• Company Name: SURETEX LIMITED - BRANCH
• Device Count: 1008
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	30070907074009 [Primary]
GS1	80070907324451 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160399
• Premarket Notification: K171172

FDA Product Code

• MOL: Condom, Synthetic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-17
• Device Publish Date: 2020-07-09

On-Brand Devices [SKYN]

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• 00070907275122: LIFESTYLES SKYN EXTRA LUBRICATED 2 DZ 12S CIR
• 00070907274125: SKYN LARGE 12 (SKYN Elite Large 12ct)
• 00070907273241: LIFESTYLES SKYN ORIGINAL 24S CIR
• 00070907273128: SKYN LIFESTYLES ORIGINAL 12
• 30070907272108: Skyn Elite 10 ct
• 00070907271247: SKYN SELECTION 24 CT - contains original, extra lubricated, extra studded
• 00070907271100: SKYN SELECTION 10 CT. 2 DZ. HT - contains original, extra lubricated, extra studded
• 00070907271032: LIFESTYLES SKYN SELECTION 3S CIR - contains original, extra lubricated, extra studded
• 00070907254158: Skyn Elite 22 ct
• 30070907229812: Skyn Elite 36 ct
• 00070907211014: LIFESTYLES SKYN EXTRA STUDDED 3CT
• 00070907209394: LIFESTYLES SKYN EXTRA STUDDED 22CT
• 00070907209363: LIFESTYLES SKYN EXTRA STUDDED 2DZ 10S
• 00070907074039: LIFESTYLES SKYN LARGE 3S CIR
• 00070907073032: LIFESTYLES SKYN ORIGINAL 3S CIR
• 30070907024424: Skyn All Night Long Personal Lubricant
• 30070907024417: Skyn Aqua Feel Personal Lubricant
• 30070907078007: LIFESTYLES NON-LATEX PI STRIPS 1000S (LS NON-LATEX PI STRIPS 1000S)
• 10070907030360: SKYN NATURAL CHEMISTRY LUBRICANT BTL 80ML
• 10070907271114: SKYN SELECTION 10CT. (CONTAINS: SKYN ORIGINAL, SKYN EXTRA LUBRICATED AND SKYN EXTRA STUDDED)
• 30070907230030: SKYN ELITE 12CT
• 30070907202075: SKYN SELECTION 12CT (CONTAINS SKYN ORIGINAL, SKYN EXTRA STUDDED, SKYN ELITE EXTRA LUBE, SKYN ELI
• 80070907324451: SKYN LARGE STPS 1000s
• 80070907324444: SKYN ORIGINAL STRIPS 1000s
• 10070907282028: SKYN MAXIMUM PERFORMANCE PERSONAL LUBRICANT
• 10070907282011: SKYN NATURAL FEEL PERSONAL LUBRICANT
• 80070907695667: SKYN ORIGINAL 36CT
• 80070907695681: SKYN ELITE 50CT TIN
• 10070907231200: SKYN EXCITATION 24CT
• 10070907231187: SKYN EXCITATION 3CT
• 10070907231026: SKYN EXCITATION 12CT
• 10070907000189: SKYN SELECTION (NEW MIX)
• 10070907000172: SKYN SELECTION 12CT
• 10070907000165: SKYN SELECTION 36CT
• 10070907000158: SKYN ELITE EXTRA LUBE 36CT
• 10070907000141: SKYN ELITE LARGE 36CT
• 10070907000622: SKYN ELITE NON LATEX CONDOM 1008
• 10070907000592: SKYN ELITE LARGE NON LATEX CONDOM 1008
• 10070907000394: SKYN ORIGINAL NON LATEX CONDOM 1008
• 10070907000868: SKYN SNUG FIT 12CT
• 10070907000745: SKYN ELITE 46CT
• 10070907001025: SKYN Classic Pack 2CT (SKYN ORIGINAL)
• 80070907101120: SKYN NATURALLY ENDLESS SACHET 5ml
• 00070907001080: SKYN ELITE 12CT + 1 NATURALLY ENDLESS SACHET
• 00070907001073: SKYN ORIGINAL 12CT + 1 NATURALLY ENDLESS SACHET
• 10070907001261: Skyn All Night Long Personal Lubricant 8.5fl oz (250ml)
• 10070907001254: Skyn All Night Long Personal Lubricant 6.8fl oz (200ml)