PDI® Adhesive Tape Remover Pad

Basic Information

• Brand Name: PDI® Adhesive Tape Remover Pad
• Primary DI: 00310819000451
• Version / Model: B16400
• Catalog Number: B16400
• Company Name: PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.
• Labeler DUNS: 800777117
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-03
• Public Version: 1
• Public Version Date: 2020-08-11
• Public Version Status: New
• Public Device Record Key: 6bf0f31c-d9e3-4c1f-bbb5-fd230102619a

Device Description

To remove adhesive tape from skin.

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KOX	Solvent, Adhesive Tape	General, Plastic Surgery	878.4730	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60494	Patient medical adhesive remover	A liquid solvent intended for removal of medical adhesive/adhered devices (e.g., residual adhesive, adhesive tape, ostomy devices) from a patient’s skin. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10310819000458	GS1	box	100	In Commercial Distribution
Primary	00310819000451	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Length	1.2	Inch
Height	2.6	Inch