Henry Schein

Basic Information

• Brand Name: Henry Schein
• Primary DI: H70110166551
• Version / Model: 1016655
• Catalog Number: 1016655
• Company Name: HENRY SCHEIN, INC.
• Labeler DUNS: 012430880
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 24
• Record Status: Published
• Publish Date: 2019-01-31
• Public Version: 2
• Public Version Date: 2019-10-23
• Public Version Status: Update
• Public Device Record Key: 552bf92f-4aa2-4947-a97c-0b9907923245

Device Description

Transparent Surgical Tape

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
KGX	Tape and bandage, adhesive	General Hospital	880.5240	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34831	Hypoallergenic skin adhesive tape	A flexible band of fabric, plastic, paper, or other material, coated on one side with a pressure-sensitive adhesive, and designed with a lower potential for producing an allergic reaction (i.e., hypoallergenic), intended to non-invasively adhere to the skin surface to fix a dressing in place, or attach objects (e.g., catheter); it is not waterproof. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	H70110166551	HIBCC
Unit of Use	H70110166559	HIBCC