ABBy

Basic Information

• Brand Name: ABBy
• Primary DI: 00814247021144
• Version / Model: PRSA-10RG
• Company Name: CLINICAL INNOVATIONS, LLC
• Labeler DUNS: 809524291
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-14
• Public Version: 1
• Public Version Date: 2023-04-24
• Public Version Status: New
• Public Device Record Key: 27aef7fd-25cc-4ec6-a672-20de8d697427

Device Description

ABBy Panniculus Retractor - 10 Regular

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KGX	Tape And Bandage, Adhesive	General Hospital	880.5240	1

GMDN Terms

Code	Name	Definition	Implantable	Status
66724	Panniculus skin-adhesive retractor, reusable	A noninvasive adhesive band/tape intended to be adhered to the skin to retract panniculus abdominal tissue following surgery, to facilitate healing of the surgical wound. It is typically used on bariatric patients or patients with redundant tissue following Caesarean section delivery or abdominal surgery; it may be removed and re-applied by the patient during the healing period. This is a single-patient reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10814247021141	GS1		10	In Commercial Distribution
Primary	00814247021144	GS1