MARTIN LEWIS G.C. SYSTEM

Basic Information

• Brand Name: MARTIN LEWIS G.C. SYSTEM
• Primary DI: M2027657ML2
• Version / Model: 7-657-ML
• Catalog Number: 7-657-ML
• Company Name: Healthlink
• Labeler DUNS: 079376107
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 9a1d884b-91b2-4af6-ad69-502c949160e7

Device Description

MARTIN LEWIS G.C. SYSTEM

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• 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
JTY	CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA	Microbiology	866.2410	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58646	Neiserria species agar culture medium IVD, basic	A selective and/or differential agar culture medium intended to be used for the growth and isolation of Neisseria gonorrhoea and/or other Neisseria species from a clinical specimen.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	M2027657ML3	HIBCC	Box	12	In Commercial Distribution
Primary	M2027657ML2	HIBCC
Unit of Use	M2027657ML0	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K950196	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	100	Millimeter
Device Size Text, specify			100 mm

Storage Conditions

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