PelashieldAM

GUDID 00850019162134

PelashieldAM™ is a sterile, single use absorbent polymeric wound matrix composed primarily of bioresorbable polyvinyl alcohol with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.16 mg/sqin. PelashieldAM™ is intended for the management of wounds. The device is packaged in sterile, sealed single pouches.

IMBED BIOSCIENCES, INC

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

• Primary Device ID: 00850019162134
• NIH Device Record Key: 528a34d1-1171-4d71-8103-95f134a5fbf5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PelashieldAM
• Version Model Number: PS1023
• 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: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• 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: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com

Device Dimensions

• Area/Surface Area: 230 Square centimeter
• Area/Surface Area: 230 Square centimeter
• Area/Surface Area: 230 Square centimeter
• Area/Surface Area: 230 Square centimeter
• Area/Surface Area: 230 Square centimeter
• Area/Surface Area: 230 Square centimeter
• Area/Surface Area: 230 Square centimeter
• Area/Surface Area: 230 Square centimeter
• Area/Surface Area: 230 Square centimeter
• Area/Surface Area: 230 Square centimeter
• Area/Surface Area: 230 Square centimeter
• Area/Surface Area: 230 Square centimeter
• Area/Surface Area: 230 Square centimeter
• Area/Surface Area: 230 Square centimeter
• Area/Surface Area: 230 Square centimeter
• Area/Surface Area: 230 Square centimeter
• Area/Surface Area: 230 Square centimeter
• Area/Surface Area: 230 Square centimeter
• Area/Surface Area: 230 Square centimeter
• Area/Surface Area: 230 Square centimeter
• Area/Surface Area: 230 Square centimeter
• Area/Surface Area: 230 Square centimeter
• Area/Surface Area: 230 Square centimeter
• Area/Surface Area: 230 Square centimeter
• Area/Surface Area: 230 Square centimeter
• Area/Surface Area: 230 Square centimeter
• Area/Surface Area: 230 Square centimeter
• Area/Surface Area: 230 Square centimeter
• Area/Surface Area: 230 Square centimeter
• Area/Surface Area: 230 Square centimeter
• Area/Surface Area: 230 Square centimeter
• Area/Surface Area: 230 Square centimeter
• Area/Surface Area: 230 Square centimeter
• Area/Surface Area: 230 Square centimeter
• Area/Surface Area: 230 Square centimeter
• Area/Surface Area: 230 Square centimeter
• Area/Surface Area: 230 Square centimeter
• Area/Surface Area: 230 Square centimeter
• Area/Surface Area: 230 Square centimeter
• Area/Surface Area: 230 Square centimeter
• Area/Surface Area: 230 Square centimeter
• Area/Surface Area: 230 Square centimeter

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
• 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
• 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	00850019162134 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153756

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: 2023-02-10
• Device Publish Date: 2023-02-02

On-Brand Devices [PelashieldAM]

• 00850019162141: PelashieldAM™ is a sterile, single use absorbent polymeric wound matrix composed primarily of
• 00850019162134: PelashieldAM™ is a sterile, single use absorbent polymeric wound matrix composed primarily of
• 00850019162127: PelashieldAM™ is a sterile, single use absorbent polymeric wound matrix composed primarily of