allDrain PCN-P7

GUDID 10812261012282

allDrain Percutaneous Nephrostomy Catheter Pigtail- 7F, 30cm

ALLWIN MEDICAL DEVICES, INC.

Nephrostomy catheter Nephrostomy catheter Nephrostomy catheter Nephrostomy catheter Nephrostomy catheter Nephrostomy catheter Nephrostomy catheter Nephrostomy catheter Nephrostomy catheter Nephrostomy catheter Nephrostomy catheter Nephrostomy catheter Nephrostomy catheter Nephrostomy catheter Nephrostomy catheter Nephrostomy catheter
Primary Device ID10812261012282
NIH Device Record Keye5988580-29cd-4d4b-905d-4ddca7267a27
Commercial Distribution StatusIn Commercial Distribution
Brand NameallDrain
Version Model NumberallDrain Percutaneous Nephrostomy Catheter Pigtail
Catalog NumberPCN-P7
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
GS100812261012285 [Primary]
GS110812261012282 [Package]
Contains: 00812261012285
Package: Box Packing [10 Units]
In Commercial Distribution

FDA Product Code

GBOCatheter, Nephrostomy, General & Plastic Surgery

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.

00812261016597 - ASPI2024-02-16 ASPI Aspiration Needle 22G,30cm
10819374020401 - Krait2023-08-09 Krait Ureteral Catheter Open Tip 4F, 70cm
10819374020418 - Krait2023-08-09 Krait Ureteral Catheter Open Tip 3F, 70cm
10819374022382 - Krait2023-08-09 Krait Ureteral Catheter Closed Tip 3F, 70cm
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
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.