V-ICSIPET TROPHECTODERM BIOPSY

Basic Information

• Brand Name: V-ICSIPET TROPHECTODERM BIOPSY
• Primary DI: 04260531791013
• Version / Model: V-ICSIPET Trophectoderm Biopsy 35
• Catalog Number: V-TEBP-V1-35
• Company Name: VITROMED GmbH
• Labeler DUNS: 342250668
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2022-03-01
• Public Version: 1
• Public Version Date: 2022-03-09
• Public Version Status: New
• Public Device Record Key: 784f4d27-bf6b-406d-b497-05a27206f36b

Device Description

V-ICSIPET is a borosilicate glass micropipette for use in assisted reproduction. The pipettes are available with different tips, inner diameters and angles. V-ICSIPET TROPHECTODERM BIOPSY pipettes are for the collection of trophectoderm cells for subsequent preimplantation genetic diagnosis.

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: Yes
• 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
PUC	Microtools, Assisted Reproduction (Pipettes), Exempt	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
Unit of Use	04260531791297	GS1
Primary	04260531791013	GS1