ABBy

GUDID 10814247021127

ABBy Panniculus Retractor - 05 Regular

CLINICAL INNOVATIONS, LLC

Panniculus skin-adhesive retractor, reusable

• Primary Device ID: 10814247021127
• NIH Device Record Key: 0fc6894d-39fb-4b4c-9dff-2ae75a017f51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ABBy
• Version Model Number: PRSA-05RG
• Company DUNS: 809524291
• Company Name: CLINICAL INNOVATIONS, LLC
• 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: false
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814247021120 [Primary]
GS1	10814247021127 [Package]; Contains: 00814247021120; Package: [5 Units]; In Commercial Distribution

FDA Product Code

• KGX: Tape And Bandage, Adhesive

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-24
• Device Publish Date: 2023-04-14

On-Brand Devices [ABBy]

• 00814247021182: ABBy Panniculus Retractor - Eval Kit
• 10814247021172: ABBy Panniculus Retractor - 10 Small
• 10814247021165: ABBy Panniculus Retractor - 05 Small
• 10814247021158: ABBy Panniculus Retractor - 10 Extra Large
• 10814247021141: ABBy Panniculus Retractor - 10 Regular
• 10814247021134: ABBy Panniculus Retractor - 05 Extra Large
• 10814247021127: ABBy Panniculus Retractor - 05 Regular