HCS

Basic Information

• Brand Name: HCS
• Primary DI: 00849027004697
• Version / Model: HCS5025TS
• Company Name: DYAD MEDICAL SOURCING, LLC
• Labeler DUNS: 078572603
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-11-16
• Public Version: 1
• Public Version Date: 2020-11-24
• Public Version Status: New
• Public Device Record Key: 5e95e6d2-c6d3-4798-b068-2ac871db420c

Device Description

2" x 5 yd Self-Adherent Bandage, Sterile, Latex Free, Tan

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: 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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FQM	Bandage, Elastic	General Hospital	880.5075	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58964	Non-adhesive device retention bandage	A piece or roll of material intended to be wrapped around a part of the body to secure a device (e.g., skin dressing, catheter, cannula) to the patient, without adhering to or compressing the body. It may be made from a variety or combination of materials, including cotton, viscose, and plastic (e.g., polyamide), and some types are cohesive (i.e., the bandage adheres to itself but not to other surfaces); it is used in various clinical specialties (e.g., dermatology, general/plastic surgery). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10849027004694	GS1	case	36	In Commercial Distribution
Primary	00849027004697	GS1