ICSI Pipette

Basic Information

• Brand Name: ICSI Pipette
• Primary DI: 10805360017685
• Version / Model: 15444
• Company Name: VITROLIFE INC.
• Labeler DUNS: 051915038
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 4
• Public Version Date: 2020-04-29
• Public Version Status: Update
• Public Device Record Key: e2eb84a3-d14d-4be7-b81c-5487e3360aca

Device Characteristics

• Single Use: Yes
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
MQH	Microtools, Assisted Reproduction (Pipettes)	Obstetrics/Gynecology	884.6130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46553	Assisted reproduction microtool	A dedicated pipette or other device used in the laboratory to denude, micromanipulate, hold, or transfer human gametes or embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10805360017685	GS1
Unit of Use	00805360017688	GS1

Premarket Submissions

Submission Number	Supplement Number
K991104	000