Silicone Bandage

Basic Information

• Brand Name: Silicone Bandage
• Primary DI: 08800109203300
• Version / Model: ABST-1-1
• Company Name: AP MDS Co., Ltd.
• Labeler DUNS: 694741911
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-04-19
• Public Version: 2
• Public Version Date: 2025-05-20
• Public Version Status: Update
• Public Device Record Key: 6d3b2fbe-23da-49b0-8655-0a9bcfb5528c

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KGX	Tape And Bandage, Adhesive	General Hospital	880.5240	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58749	Dressing-fixation skin adhesive tape, silicone	A long and narrow flexible band of plastic, fabric or other material, with an adhesive layer made of soft silicone, designed to cover a surface (e.g., small wound), fix a dressing, or attach objects/devices to the body. The silicone layer is intended to be less allergenic and to allow for easy removal with less trauma to skin and less adhesion to bodily hair than conventional pressure-sensitive adhesives. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	18800109203307	GS1		12	In Commercial Distribution
Primary	08800109203300	GS1
Package	28800109203304	GS1		216	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

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