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

Needle, Assisted Reproduction (MQE) (4) Cannula, Intrauterine Insemination (MFD) (3) Catheter, Assisted Reproduction (MQF) (2)

Premarket Exempt

No Yes

Clear

Curved Insemina Intra Uterine Insemination Catheter Open Tip - 00819374021890 Catalog Number : I-IUI-C-O

Device Class : 2

Duns Number: 796354509

Premarket Exempt : No

Product Code : MFD

Prescription Use : Yes

Device Count : 1

ACE-M - 00819374021906 Catalog Number : A-OVM-SL17-35-M

Device Description : ACE-M Manual Single Lumen Ovum Pickup Needle 17G, 35 cm

Device Class : 2

Duns Number: 796354509

Premarket Exempt : No

Product Code : MQE

Prescription Use : Yes

Device Count : 1

Trackable Intra Uterine Insemination Catheter Open Tip - 00819374022019 Catalog Number : T-IUI-O

Device Class : 2

Duns Number: 796354509

Premarket Exempt : No

Product Code : MFD

Prescription Use : Yes

Device Count : 1

ACE - 00819374022460 Catalog Number : A-OVM-SL 16/35

Device Description : ACE Single Lumen Ovum Pickup Needle 16G, 35cm

Device Class : 2

Duns Number: 796354509

Premarket Exempt : No

Product Code : MQE

Prescription Use : Yes

Device Count : 1

ACE-M - 00819374022477 Catalog Number : A-OVM-SL 16/35 - M

Device Description : ACE-M Manual Single Lumen Ovum Pickup Needle 16G, 35 cm

Device Class : 2

Duns Number: 796354509

Premarket Exempt : No

Product Code : MQE

Prescription Use : Yes

Device Count : 1

ACE-M - 00819374022484 Catalog Number : A-OVM-SL 18/35-M

Device Description : ACE-M Manual Single Lumen Ovum Pickup Needle 18G, 35 cm

Device Class : 2

Duns Number: 796354509

Premarket Exempt : No

Product Code : MQE

Prescription Use : Yes

Device Count : 1

Flexi Intra Uterine Insemination Catheter Open Tip - 00819374022491 Catalog Number : F-IUI-O

Device Class : 2

Duns Number: 796354509

Premarket Exempt : No

Product Code : MFD

Prescription Use : Yes

Device Count : 1

Soft Obturator for Twinkle Pro Embryo Trans - 00819374022521 Catalog Number : SB-TPEB-ETC

Device Description : Soft Obturator for Twinkle Pro Embryo Trans

Device Class : 2

Duns Number: 796354509

Premarket Exempt : No

Product Code : MQF

Prescription Use : Yes

Device Count : 1

Twinkle Embryo Trans (18cm) - 00819374022538 Catalog Number : TEB-ETC18

Device Description : Twinkle Embryo Trans embryo transfer catheter (18cm)

Device Class : 2

Duns Number: 796354509

Premarket Exempt : No

Product Code : MQF

Prescription Use : Yes

Device Count : 1

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