HIMS

GUDID 18859798101319

hims Climax Delayed Latex Condom 8ct

SURETEX LIMITED - BRANCH

Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, synthetic polymer Basic male condom, synthetic polymer Basic male condom, synthetic polymer Basic male condom, synthetic polymer Basic male condom, synthetic polymer Basic male condom, synthetic polymer Basic male condom, synthetic polymer Basic male condom, synthetic polymer Basic male condom, synthetic polymer Basic male condom, synthetic polymer Basic male condom, synthetic polymer Basic male condom, synthetic polymer Basic male condom, synthetic polymer

• Primary Device ID: 18859798101319
• NIH Device Record Key: 3319e8e8-a11f-4c61-9d07-c0dcd76355e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HIMS
• Version Model Number: 08859798101312
• Company DUNS: 672044515
• Company Name: SURETEX LIMITED - BRANCH
• Device Count: 8
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08859798101312 [Primary]
GS1	18859798101319 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030176
• Premarket Notification: K171172

FDA Product Code

• HIS: Condom
• 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: 2023-10-06
• Device Publish Date: 2023-09-28

On-Brand Devices [HIMS]

• 18859798101319: hims Climax Delayed Latex Condom 8ct
• 18859798101180: hims Climax Delayed Latex Condom 8ct