GETANE

GUDID 06925634004061

Suzhou Colourway New Material Co., Ltd.

Basic male condom, Hevea-latex

• Primary Device ID: 06925634004061
• NIH Device Record Key: e0f11594-118f-41a4-910d-fa7a1616c5ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GETANE
• Version Model Number: Ice and fire Male Latex Condoms, medium (53 ± 2mm)
• Company DUNS: 544612070
• Company Name: Suzhou Colourway New Material Co., Ltd.
• Device Count: 1
• 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: true
• 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	06925634004061 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083817

FDA Product Code

• HIS: Condom

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: 2025-04-11
• Device Publish Date: 2025-04-03

On-Brand Devices [GETANE]

• 06925634004030: Ultra-thin, medium (53 ± 2mm) thickness: 0.045 ± 0
• 06925634004092: Active ribbed Male Latex Condoms, medium (53 ± 2mm
• 06925634004085: Super smooth and moisturizing Male, medium (53 ± 2
• 06925634004078: Fragrance sexy fun strawberry Male, medium (53 ± 2
• 06925634004061: Ice and fire Male Latex Condoms, medium (53 ± 2mm)