Exorb Ankle Large ECA300

GUDID 00850051939398

A wound cover that wraps around the ankle which is intended to be used as an initial, short-term treatment after injury that consists of an high drainage absorbent pad (e.g., gauze, cotton wool, lint, cellulose) The device is intended for use in the home or a clinical setting to protect wounds, arrest bleeding. This is a single-use device.

SUN SCIENTIFIC, INC.

First aid absorbent pad/bandage

• Primary Device ID: 00850051939398
• NIH Device Record Key: 81cc4df2-d0db-4ae9-be37-0c98f7d21436
• Commercial Distribution Discontinuation: 2030-05-18
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Exorb Ankle Large
• Version Model Number: EA2350
• Catalog Number: ECA300
• Company DUNS: 609397224
• Company Name: SUN SCIENTIFIC, 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: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com
• Phone: 9144795108
• Email: aalward@sun-scientific.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850051939398 [Primary]

FDA Product Code

• NAC: Dressing, Wound, Hydrophilic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-08
• Device Publish Date: 2024-07-31

Devices Manufactured by SUN SCIENTIFIC, INC.

• 00850051939565 - AeroWrap™ Full Leg: 2024-12-13 The AeroWrap ™ Full Leg System is comprised of inflatable gradient compression sleeves, a Brace sleeve from the ankle to the k
• 00850051939572 - AeroWrap™ Full Leg: 2024-12-13 The AeroWrap ™ Full Leg System is comprised of inflatable gradient compression sleeves, a Brace sleeve from the ankle to the k
• 00850051939589 - AeroWrap™ Full Leg: 2024-12-13 The AeroWrap ™ Full Leg System is comprised of inflatable gradient compression sleeves, a Brace sleeve from the ankle to the k
• 00850051939596 - AeroWrap™ Full Leg: 2024-12-13 The AeroWrap ™ Full Leg System is comprised of inflatable gradient compression sleeves, a Brace sleeve from the ankle to the k
• 00850051939602 - AeroWrap™ Full Leg: 2024-12-13 The AeroWrap ™ Full Leg System is comprised of inflatable gradient compression sleeves, a Brace sleeve from the ankle to the k
• 00850051939619 - AeroWrap™ Full Leg: 2024-12-13 The AeroWrap ™ Full Leg System is comprised of inflatable gradient compression sleeves, a Brace sleeve from the ankle to the k
• 00850051939626 - AeroWrap™ Full Leg: 2024-12-13 The AeroWrap ™ Full Leg System is comprised of inflatable gradient compression sleeves, a Brace sleeve from the ankle to the k
• 00850051939640 - AeroWrap™ Full Leg: 2024-12-13 The AeroWrap ™ Full Leg System is comprised of inflatable gradient compression sleeves, a Brace sleeve from the ankle to the k