FDA.reportPublic FDA data

V-ICSIPET INJECTION

Primary DI
04260531791198
Brand
V-ICSIPET INJECTION
Company
VITROMED GmbH
Model
V-ICSIPET Injection without Spike 25
Catalog number
V-INJ-V1-25
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 pipettes for the manipulation of cells with the help of a micromanipulator. For intracytoplasmic injection (ICSI) of a single sperm into the oocyte (with and without spike).
Published
2022-03-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PUCMicrotools, Assisted Reproduction (Pipettes), Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUCMicrotools, Assisted Reproduction (Pipettes), ExemptObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260531790931PrimaryGS10
04260531791198Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260531790931042605317909314260531790931
04260531791198042605317911984260531791198

GMDN Terms#

Term, Definition table
TermDefinition
Assisted reproduction microtoolA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
342250668
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260650070181V-GRAD 80 (2x for V-GRAD Kit)V-GRD83_12G2025-07-03
04260650070082V-GRAD 40 (2x for V-GRAD Kit)V-GRD43_12G2025-07-03
04260650070280V-GRAD 80 (2x for V-GRAD Kit)V-GRD83_12G2025-07-03
04260650070303V-GRAD 40V-GRD43_100P2025-07-03
04260650071102V-GRAD 80V-GRD83_100P2025-07-03
04260650071201V-GRAD 100V-GRD00_100P2025-07-03
04260531790009V-DENUPETV-DENUPET 125V-DEN-1252022-03-01
04260531790016V-DENUPETV-DENUPET 135V-DEN-1352022-03-01
04260531790023V-DENUPETV-DENUPET 140V-DEN-1402022-03-01
04260531790030V-DENUPETV-DENUPET 150V-DEN-1502022-03-01
04260531790054V-DENUPETV-DENUPET 175V-DEN-1752022-03-01
04260531790061V-DENUPETV-DENUPET 200V-DEN-2002022-03-01
04260531790078V-DENUPETV-DENUPET 275V-DEN-2752022-03-01
04260531790085V-DENUPETV-DENUPET 300V-DEN-3002022-03-01
04260531790092V-DENUPETV-DENUPET 600V-DEN-6002022-03-01
04260650070341V-VITWARMV-TS-KIT2024-11-16
04260650070297V-VITWARMV-TS-KIT2024-11-16
04260650070327V-VITFREEZEV-FS-KIT2024-10-16
04260650070273V-VITFREEZEV-FS-KIT2024-10-16
04260650071034V-PVPV-PVP-72024-05-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04580842321885Kitazato Holding MicropipetteKITAZATO CORPORATIONPUC2026-07-13
10816633020776SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020783SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020790SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020806SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020813SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020820SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020837SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020844SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020851SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020868SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020875SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020899SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020905SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020912SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020929SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020936SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020943SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020950SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020967SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020974SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020981SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633020998SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633021957SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633021964SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633021971SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633021988SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633021995SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633022497SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27
10816633022503SLMSUNLIGHT MEDICAL, INC.PUC2024-03-27