All Soft Ureteral Stent - 7F, 24cm with Suture SOT 7/24-S

GUDID 10812261010691

7F, 24cm with Suture

ALLWIN MEDICAL DEVICES, INC.

Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent Polymeric ureteral stent
Primary Device ID10812261010691
NIH Device Record Key8ccde8dd-88a8-49fb-88c0-50eaea481652
Commercial Distribution StatusIn Commercial Distribution
Brand NameAll Soft Ureteral Stent - 7F, 24cm with Suture
Version Model Number7F, 24cm with Suture
Catalog NumberSOT 7/24-S
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 Latextrue
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
GS100812261010694 [Primary]
GS110812261010691 [Package]
Contains: 00812261010694
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FADStent, Ureteral

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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