Lucky Super Soft

GUDID 00808829127065

First Aid Bandages Wihout Drug (With no drug, Adhesive bandages in a variety of different sizes and shapes )Identification. A medical adhesive tape or adhesive bandage is a device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

DELTA BRANDS INC.

Skin-cover adhesive strip, non-antimicrobial

• Primary Device ID: 00808829127065
• NIH Device Record Key: abfc4230-e366-4e18-87ab-4c00c3ee4861
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lucky Super Soft
• Version Model Number: Bandages in differenet size
• Company DUNS: 102672008
• Company Name: DELTA BRANDS INC.
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00808829127065 [Primary]

FDA Product Code

• KGX: Tape And Bandage, Adhesive

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[00808829127065]

Ethylene Oxide

[00808829127065]

Ethylene Oxide

[00808829127065]

Ethylene Oxide

[00808829127065]

Ethylene Oxide

[00808829127065]

Ethylene Oxide

[00808829127065]

Ethylene Oxide

[00808829127065]

Ethylene Oxide

[00808829127065]

Ethylene Oxide

[00808829127065]

Ethylene Oxide

[00808829127065]

Ethylene Oxide

[00808829127065]

Ethylene Oxide

[00808829127065]

Ethylene Oxide

[00808829127065]

Ethylene Oxide

[00808829127065]

Ethylene Oxide

[00808829127065]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-20
• Device Publish Date: 2024-05-10

On-Brand Devices [Lucky Super Soft]

• 00808829120325: First Aid Bandages Wihout Drug (With no drug, Adhesive bandages in a variety of different sizes
• 00808829124170: First Aid Bandages Wihout Drug (With no drug, Adhesive bandages in a variety of different sizes
• 00808829127065: First Aid Bandages Wihout Drug (With no drug, Adhesive bandages in a variety of different sizes