ALLWIN MEDICAL DEVICES, INC.

Address:3305 E. MIRALOMA AVENUE,ANAHEIM,CA,92806,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Stent, Ureteral (FAD) (7) Dilator, Urethral (KOE) (2) Adaptor, Bulbs, Miscellaneous, For Endoscope (FFY) (1)

Premarket Exempt

No Yes

Clear

All Soft Ureteral Stent - 6F, 22cm with Suture - 00812261010007 Catalog Number : SOT 6/22-S

Device Description : 6F, 22cm with Suture

Device Class : 2

Duns Number: 796354509

Premarket Exempt : No

Product Code : FAD

Prescription Use : Yes

Device Count : 1

All Soft Ureteral Stent - 6F, 24cm - 00812261010113 Catalog Number : SOT 6/24

Device Description : Ureteral Stent - 6F, 24cm

Device Class : 2

Duns Number: 796354509

Premarket Exempt : No

Product Code : FAD

Prescription Use : Yes

Device Count : 1

All Soft Ureteral Stent - 6F, 26cm - 00812261010120 Catalog Number : SOT 6/26

Device Description : 6F, 26cm

Device Class : 2

Duns Number: 796354509

Premarket Exempt : No

Product Code : FAD

Prescription Use : Yes

Device Count : 1

All Soft Ureteral Stent - 6F, 24cm with Suture - 00812261010663 Catalog Number : SOT 6/24-S

Device Description : Ureteral Stent - 6F, 24cm with Suture

Device Class : 2

Duns Number: 796354509

Premarket Exempt : No

Product Code : FAD

Prescription Use : Yes

Device Count : 1

All Soft Ureteral Stent - 7F, 24cm with Suture - 00812261010694 Catalog Number : SOT 7/24-S

Device Description : 7F, 24cm with Suture

Device Class : 2

Duns Number: 796354509

Premarket Exempt : No

Product Code : FAD

Prescription Use : Yes

Device Count : 1

Meatal Dilator Adult - 00812261012988 Catalog Number : MDA

Device Class : 2

Duns Number: 796354509

Premarket Exempt : Yes

Product Code : KOE

Prescription Use : Yes

Device Count : 1

Meatal Dilator Pediatric - 00812261012995 Catalog Number : MDP

Device Class : 2

Duns Number: 796354509

Premarket Exempt : Yes

Product Code : KOE

Prescription Use : Yes

Device Count : 1

All Soft Ureteral Stent - 7F, 22cm with Suture - 00812261013213 Catalog Number : SOT 7/22-S

Device Description : 7F, 22cm with Suture

Device Class : 2

Duns Number: 796354509

Premarket Exempt : No

Product Code : FAD

Prescription Use : Yes

Device Count : 1

All Soft Ureteral Stent - 6F, 26cm with Suture - 00812261013756 Catalog Number : SOT 6/26-S

Device Description : All Soft Ureteral Stent - 6F, 26cm with Suture

Device Class : 2

Duns Number: 796354509

Premarket Exempt : No

Product Code : FAD

Prescription Use : Yes

Device Count : 1

Trackfinder - 00812261014401 Catalog Number : TF

Device Description : Trackfinder Bladder Evacuator

Device Class : 1

Duns Number: 796354509

Premarket Exempt : Yes

Product Code : FFY

Prescription Use : Yes

Device Count : 1

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