Pantex P631SC

Basic Information

• Brand Name: Pantex P631SC
• Primary DI: 00850039602009
• Version / Model: P631SC
• Catalog Number: 631
• Company Name: Pantex
• Labeler DUNS: 072296809
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-23
• Public Version: 4
• Public Version Date: 2023-03-10
• Public Version Status: Update
• Public Device Record Key: 3495dcdc-7e04-43d1-97f7-6a01749808fc

Device Description

Gargg Plate - 96 Wells

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Manufacturing Date: No
• 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
NHG	Enzyme Immunoassay, Cortisol, Salivary	Clinical Chemistry	862.1205	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62281	Total cortisol IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total cortisol in a clinical specimen, using an enzyme immunoassay (EIA) method. It is used as an aid in the diagnosis and treatment of adrenal disorders.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850039602009	GS1
Package	10850039602006	GS1	Foil	1	Not in Commercial Distribution	2023-02-17
Package	40850039602007	GS1	Foil	1	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius