HYSTERO CATH HC-HSG7

GUDID 00812261016689

HYSTERO CATH Hysterosalpingography Catheter Closed Tip

ALLWIN MEDICAL DEVICES, INC.

Intrauterine imaging medium catheter Intrauterine imaging medium catheter Intrauterine imaging medium catheter Intrauterine imaging medium catheter Intrauterine imaging medium catheter Intrauterine imaging medium catheter Intrauterine imaging medium catheter Intrauterine imaging medium catheter Intrauterine imaging medium catheter Intrauterine imaging medium catheter Intrauterine imaging medium catheter Intrauterine imaging medium catheter Intrauterine imaging medium catheter Intrauterine imaging medium catheter Intrauterine imaging medium catheter Intrauterine imaging medium catheter
Primary Device ID00812261016689
NIH Device Record Key4f8fdb7f-9f83-4395-b2e4-a93f949b36ef
Commercial Distribution StatusIn Commercial Distribution
Brand NameHYSTERO CATH
Version Model NumberHYSTERO CATH Hysterosalpingography Catheter Closed
Catalog NumberHC-HSG7
Company DUNS796354509
Company NameALLWIN MEDICAL DEVICES, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Perscriptionfalse
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
Phone714-572-1709
Emailinfo@allwinmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100812261016689 [Primary]
GS110812261016686 [Package]
Package: Box Packing [5 Units]
In Commercial Distribution

FDA Product Code

LKFCannula, Manipulator/Injector, Uterine

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-07
Device Publish Date2023-07-28

Devices Manufactured by ALLWIN MEDICAL DEVICES, INC.

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10819374022382 - Krait2023-08-09 Krait Ureteral Catheter Closed Tip 3F, 70cm
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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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