INTEGRA 3

Basic Information

• Brand Name: INTEGRA 3
• Primary DI: 05060488044755
• Version / Model: Integra 3 Thermosafe Nikon Ti2 No Syringes
• Catalog Number: 6-54-100-14
• Company Name: RESEARCH INSTRUMENTS LIMITED
• Labeler DUNS: 536139413
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-23
• Public Version: 5
• Public Version Date: 2024-02-28
• Public Version Status: Update
• Public Device Record Key: 9a9e2ec5-5bc5-4914-b460-44f686ff1835

Device Description

Assisted Reproduction Micromanipulator and Microinjector

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
MQJ	Micromanipulators and microinjectors, assisted reproduction	Obstetrics/Gynecology	884.6150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34169	Assisted reproduction electromechanical micromanipulator	An electrically-powered device designed for accurate manipulation of microscopic objects during laboratory in vitro assisted reproduction techniques (ART) [e.g., intracytoplasmic sperm injection] usually by making small movements under the visual field of a laboratory microscope. It includes precision motors that reproduce the movements of the hand on a microscopic scale (continuous or step-by-step movements performed with an input mechanism such as a joystick) applied to miniature tools which may be included (e.g., fine needles, syringe microinjectors, capillary tubes). The device does not perform its actions following a computerized program.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060488044755	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K003142	000