GoodSense

Basic Information

• Brand Name: GoodSense
• Primary DI: 00180410000231
• Version / Model: 180410000231
• Company Name: GEISS, DESTIN & DUNN, INC
• Labeler DUNS: 076059836
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-28
• Public Version: 2
• Public Version Date: 2021-12-08
• Public Version Status: Update
• Public Device Record Key: 39c4a3d8-4076-4dec-9069-7704925c5f67

Device Description

Tender Tape, 2 IN x 5 YDS (50 mm x 4.5 m) stretched; 2 IN x 2.2 YDS (50 mm x 2 m)

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: 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: 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
FQM	Bandage, Elastic	General Hospital	880.5075	1

GMDN Terms

Code	Name	Definition	Implantable	Status
10284	Pressure bandage, non-latex, single-use	A strip or roll of fabric or plastic material (non-natural rubber latex) intended to be applied to and compress a local area of the body for one or more preventative/therapeutic applications (e.g., prevent oedema, support injuries associated with minor trauma, treat disorders of venous return). It may be described as a sports tape intended for support while allowing movement, or described as a compression bandage; it is not intended to be used in association with open wounds. It is intended for use in the home or healthcare facility. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10180410000238	GS1	case	72	In Commercial Distribution
Primary	00180410000231	GS1