HIMS

GUDID 18859798101319

hims Climax Delayed Latex Condom 8ct

SURETEX LIMITED - BRANCH

Basic male condom, Hevea-latex

• 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