DERMATOUCH

Basic Information

• Brand Name: DERMATOUCH
• Primary DI: 00810169801864
• Version / Model: 81140MD/M
• Company Name: PRIME SOLUTIONS, INC.
• Labeler DUNS: 093300590
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2025-12-15
• Public Version: 1
• Public Version Date: 2025-12-23
• Public Version Status: New
• Public Device Record Key: 1c4dbf29-b539-469b-ae26-71d8e8855f52

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: No
• 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
LZA	Polymer Patient Examination Glove	General Hospital	880.6250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
56186	Coagulation factor XI inhibitor IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of coagulation factor XI inhibitor in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00810169801932	GS1	CASE	10	In Commercial Distribution
Primary	00810169801864	GS1
Unit of Use	10810169801861	GS1