GM501 Gradient 90%

Basic Information

• Brand Name: GM501 Gradient 90%
• Primary DI: 00858604006191
• Version / Model: 4GM501GR-90-100
• Company Name: HAMILTON THORNE, INC.
• Labeler DUNS: 152161337
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-30
• Public Version: 1
• Public Version Date: 2021-05-10
• Public Version Status: New
• Public Device Record Key: c7d52b3d-2d24-49cf-a596-6cfa7ac97226

Device Description

GM501 Gradient 90% is a ready-to-use gradient system for semen preparation and can be used in combination with IUI, IVF, and ICSI procedures.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: Yes
• 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MQL	Media, Reproductive	Obstetrics/Gynecology	884.6180	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41427	Cell centrifugation/density gradient separation reagent IVD	A substance or reactant intended to be used for the isolation of cells from a clinical specimen (e.g., lymphocytes from whole blood, cells from a liquid-based cytology specimen) using centrifugation and density gradient to achieve specimen component separation.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00858604006191	GS1

Premarket Submissions

Submission Number	Supplement Number
K053494	000