FDA.reportPublic FDA data

V-DENUPET

Primary DI
04260531791501
Brand
V-DENUPET
Company
VITROMED GmbH
Model
V-DENUPET 275
Catalog number
V-DEN-275
Device description
The tip of V-DENUPET is available in a range of internal diameter sizes. Sizes 125 - 175 µm are suitable for oocyte denudation, sizes 200 - 600 µm are for oocyte and embryo handling procedures.
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
MQHMicrotools, Assisted Reproduction (Pipettes)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQHMicrotools, Assisted Reproduction (Pipettes)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192146000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192146000V-DENUPETVitromed GmbH2020-01-28MQH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260531790078PrimaryGS10
04260531791501Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260531790078042605317900784260531790078
04260531791501042605317915014260531791501

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
50
DM exempt
false
Premarket exempt
false
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
05060488046858EZ-StripCoopersurgical, Inc.MQH2025-04-11
05060488046865EZ-StripCoopersurgical, Inc.MQH2025-04-11
05060488046872EZ-StripCoopersurgical, Inc.MQH2025-04-11
05060488046889EZ-StripCoopersurgical, Inc.MQH2025-04-11
05060488046896EZ-StripCoopersurgical, Inc.MQH2025-04-11
05060488046902EZ-StripCoopersurgical, Inc.MQH2025-04-11
05060488046919EZ-StripCoopersurgical, Inc.MQH2025-04-11
05060488046926EZ-StripCoopersurgical, Inc.MQH2025-04-11
05060488046933EZ-StripCoopersurgical, Inc.MQH2025-04-11
05060488046940EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488046957EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488046964EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488046971EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488046988EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488046995EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047008EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047015EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047022EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047039EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047046EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047053EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047060EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047077EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047084EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047091EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047107EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047114EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047121EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047138EZ-TipCoopersurgical, Inc.MQH2025-04-11
05060488047145EZ-TipCoopersurgical, Inc.MQH2025-04-11