Soft embryo transfer catheter

GUDID 25425017501071

Embryo transfer catheter used for introduction of embryos into the uterine cavity.

Gynetics Medical Products NV

Assisted reproduction catheter set
Primary Device ID25425017501071
NIH Device Record Key26d56685-3f3f-40c3-991d-4db24848b2f6
Commercial Distribution StatusIn Commercial Distribution
Brand NameSoft embryo transfer catheter
Version Model Number#2000 Semtrac Set 4.2
Company DUNS283088573
Company NameGynetics Medical Products NV
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+3211645872
Emailinfo@gynetics.com

Device Dimensions

Total Volume0.23 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105425017501077 [Primary]
GS115425017501074 [Package]
Contains: 05425017501077
Package: [25 Units]
In Commercial Distribution
GS125425017501071 [Package]
Contains: 05425017501077
Package: [75 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQFCatheter, Assisted Reproduction

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[25425017501071]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-10-14

On-Brand Devices [Soft embryo transfer catheter ]

25425017501118Embryo transfer catheter used for introduction of embryos into the uterine cavity.
25425017501101Embryo transfer catheter used for introduction of embryos into the uterine cavity.
25425017501088Embryo transfer catheter used for introduction of embryos into the uterine cavity.
25425017501071Embryo transfer catheter used for introduction of embryos into the uterine cavity.

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