Surgaflex PainGuard

GUDID 00850019162325

Surgaflex PainGuard, 2cm x 3cm

IMBED BIOSCIENCES, INC.

Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial

• Primary Device ID: 00850019162325
• NIH Device Record Key: e3aef86e-9455-4527-a12a-ee9cce61e4b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Surgaflex PainGuard
• Version Model Number: SFPG0203
• Company DUNS: 962084500
• Company Name: IMBED BIOSCIENCES, INC.
• 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: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 888-472-9898
• Email: cs@imbedbio.com
• Phone: 888-472-9898
• Email: cs@imbedbio.com
• Phone: 888-472-9898
• Email: cs@imbedbio.com
• Phone: 888-472-9898
• Email: cs@imbedbio.com
• Phone: 888-472-9898
• Email: cs@imbedbio.com
• Phone: 888-472-9898
• Email: cs@imbedbio.com
• Phone: 888-472-9898
• Email: cs@imbedbio.com
• Phone: 888-472-9898
• Email: cs@imbedbio.com
• Phone: 888-472-9898
• Email: cs@imbedbio.com
• Phone: 888-472-9898
• Email: cs@imbedbio.com
• Phone: 888-472-9898
• Email: cs@imbedbio.com
• Phone: 888-472-9898
• Email: cs@imbedbio.com
• Phone: 888-472-9898
• Email: cs@imbedbio.com
• Phone: 888-472-9898
• Email: cs@imbedbio.com
• Phone: 888-472-9898
• Email: cs@imbedbio.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850019162325 [Primary]

FDA Product Code

• FRO: Dressing, Wound, Drug

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: 2025-04-01
• Device Publish Date: 2025-03-24

On-Brand Devices [Surgaflex PainGuard]

• 00850019162356: Surgaflex PainGuard, 4cm x 20cm
• 00850019162349: Surgaflex PainGuard, 4cm x 10cm
• 00850019162332: Surgaflex PainGuard, 4cm x 6cm
• 00850019162325: Surgaflex PainGuard, 2cm x 3cm