pGOLD Slides

Basic Information

• Brand Name: pGOLD Slides
• Primary DI: 90860007960607
• Version / Model: NBPG-0005
• Company Name: Nirmidas Biotech, Inc.
• Labeler DUNS: 079148338
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-04-05
• Public Version: 1
• Public Version Date: 2022-04-13
• Public Version Status: New
• Public Device Record Key: dd2478ec-a621-4e01-8af3-95eed4a97749

Device Characteristics

• Single Use: No
• 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: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KEW	Slides, Microscope	Pathology	864.3010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61296	Microplate IVD	A plate with multiple wells designed to contain small volumes of clinical specimens, reagents, or other materials for testing procedures performed by a laboratory analyser. It is typically made of sterilizable plastic material (e.g., polypropylene) and is used with manual or automated analysers. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	90860007960607	GS1