Soft Obturator for Twinkle Pro Embryo Trans SB-TPEB-ETC

GUDID 10819374022528

Soft Obturator for Twinkle Pro Embryo Trans

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 ID10819374022528
NIH Device Record Key5b20569d-ca16-4dda-bc3b-f03a81b5d4cf
Commercial Distribution StatusIn Commercial Distribution
Brand NameSoft Obturator for Twinkle Pro Embryo Trans
Version Model NumberSoft Obturator for Twinkle Pro Embryo Trans
Catalog NumberSB-TPEB-ETC
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
GS100819374022521 [Primary]
GS110819374022528 [Package]
Contains: 00819374022521
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

Devices Manufactured by ALLWIN MEDICAL DEVICES, INC.

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10819374022399 - Krait2023-08-09 Krait Ureteral Catheter Closed Tip 4F, 70cm
10819374022405 - Krait2023-08-09 Krait Ureteral Catheter Closed Tip 5F, 70cm
10819374023174 - Krait2023-08-09 Krait Ureteral Catheter Closed Tip 6F, 70cm
10819374024379 - Krait2023-08-09 Krait Ureteral Catheter Open Tip 7F, 70cm

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