Silicone Bandage

GUDID 18800109203345

A long, narrow, flexible band of material with an adhesive layer made of soft silicone designed to cover a surface (e.g. a small wound), secure a dressing, or attach an object/device to the body. The silicone layer is designed to cause less allergy, cause less skin trauma than traditional pressure-sensitive adhesives, and has low adhesion to body hair for easy removal. This is a disposable device. Available in 1-inch, 2-inch, and 4-inch widths.

AP MDS Co., Ltd.

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• Primary Device ID: 18800109203345
• NIH Device Record Key: 8a24aef6-e62a-4a14-b74b-9658c9f56425
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silicone Bandage
• Version Model Number: ABST-2-2
• Company DUNS: 695407034
• Company Name: AP MDS Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 818 903 0660
• Email: dpaek.rennes@gmail.com
• Phone: 818 903 0660
• Email: dpaek.rennes@gmail.com
• Phone: 818 903 0660
• Email: dpaek.rennes@gmail.com
• Phone: 818 903 0660
• Email: dpaek.rennes@gmail.com
• Phone: 818 903 0660
• Email: dpaek.rennes@gmail.com
• Phone: 818 903 0660
• Email: dpaek.rennes@gmail.com
• Phone: 818 903 0660
• Email: dpaek.rennes@gmail.com
• Phone: 818 903 0660
• Email: dpaek.rennes@gmail.com
• Phone: 818 903 0660
• Email: dpaek.rennes@gmail.com
• Phone: 818 903 0660
• Email: dpaek.rennes@gmail.com
• Phone: 818 903 0660
• Email: dpaek.rennes@gmail.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800109203348 [Primary]
GS1	18800109203345 [Package]; Contains: 08800109203348; Package: [6 Units]; In Commercial Distribution
GS1	28800109203342 [Package]; Package: [108 Units]; In Commercial Distribution

FDA Product Code

• KGX: Tape And Bandage, Adhesive

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: 2024-04-29
• Device Publish Date: 2024-04-19

On-Brand Devices [Silicone Bandage]

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• 18800109203383: A long, narrow, flexible band of material with an adhesive layer made of soft silicone designed
• 18800109203376: A long, narrow, flexible band of material with an adhesive layer made of soft silicone designed
• 18800109203369: A long, narrow, flexible band of material with an adhesive layer made of soft silicone designed
• 18800109203352: A long, narrow, flexible band of material with an adhesive layer made of soft silicone designed
• 18800109203345: A long, narrow, flexible band of material with an adhesive layer made of soft silicone designed
• 18800109203338: A long, narrow, flexible band of material with an adhesive layer made of soft silicone designed
• 18800109203321: A long, narrow, flexible band of material with an adhesive layer made of soft silicone designed
• 18800109203314: A long, narrow, flexible band of material with an adhesive layer made of soft silicone designed
• 18800109203307: A long, narrow, flexible band of material with an adhesive layer made of soft silicone designed