Twinkle Embryo Trans (18cm) TEB-ETC18

GUDID 10819374022535

Twinkle Embryo Trans embryo transfer catheter (18cm)

ALLWIN MEDICAL DEVICES, INC.

Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set
Primary Device ID10819374022535
NIH Device Record Keydc37e129-6073-4afb-a614-11ea85be34af
Commercial Distribution StatusIn Commercial Distribution
Brand NameTwinkle Embryo Trans (18cm)
Version Model NumberEmbryo Transfer Catheter
Catalog NumberTEB-ETC18
Company DUNS796354509
Company NameALLWIN MEDICAL DEVICES, INC.
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone714-572-1709
Emailinfo@allwinmedical.com
Phone714-572-1709
Emailinfo@allwinmedical.com
Phone714-572-1709
Emailinfo@allwinmedical.com
Phone714-572-1709
Emailinfo@allwinmedical.com
Phone714-572-1709
Emailinfo@allwinmedical.com
Phone714-572-1709
Emailinfo@allwinmedical.com
Phone714-572-1709
Emailinfo@allwinmedical.com
Phone714-572-1709
Emailinfo@allwinmedical.com
Phone714-572-1709
Emailinfo@allwinmedical.com
Phone714-572-1709
Emailinfo@allwinmedical.com
Phone714-572-1709
Emailinfo@allwinmedical.com
Phone714-572-1709
Emailinfo@allwinmedical.com
Phone714-572-1709
Emailinfo@allwinmedical.com
Phone714-572-1709
Emailinfo@allwinmedical.com
Phone714-572-1709
Emailinfo@allwinmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100819374022538 [Primary]
GS110819374022535 [Package]
Contains: 00819374022538
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQFCatheter, Assisted Reproduction

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-29
Device Publish Date2020-09-21

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