allDrain PCN-P7

GUDID 10812261012282

Nephrostomy catheter

Primary Device ID	10812261012282
NIH Device Record Key	e5988580-29cd-4d4b-905d-4ddca7267a27
Commercial Distribution Status	In Commercial Distribution
Brand Name	allDrain
Version Model Number	allDrain Percutaneous Nephrostomy Catheter Pigtail
Catalog Number	PCN-P7
Company DUNS	796354509
Company Name	ALLWIN MEDICAL DEVICES, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00812261012285 [Primary]
GS1	10812261012282 [Package] Contains: 00812261012285 Package: Box Packing [10 Units] In Commercial Distribution

GBO	Catheter, Nephrostomy, General & Plastic Surgery

Steralize Prior To Use	false
Device Is Sterile	true

00812261016597 - ASPI	2024-02-16 ASPI Aspiration Needle 22G,30cm
10819374020401 - Krait	2023-08-09 Krait Ureteral Catheter Open Tip 4F, 70cm
10819374020418 - Krait	2023-08-09 Krait Ureteral Catheter Open Tip 3F, 70cm
10819374022382 - Krait	2023-08-09 Krait Ureteral Catheter Closed Tip 3F, 70cm
10819374022399 - Krait	2023-08-09 Krait Ureteral Catheter Closed Tip 4F, 70cm
10819374022405 - Krait	2023-08-09 Krait Ureteral Catheter Closed Tip 5F, 70cm
10819374023174 - Krait	2023-08-09 Krait Ureteral Catheter Closed Tip 6F, 70cm
10819374024379 - Krait	2023-08-09 Krait Ureteral Catheter Open Tip 7F, 70cm