CROSS BAY MEDICAL, INC.

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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

Curette, Suction, Endometrial (And Accessories) (HHK) (2)

Premarket Exempt

Clear

CrossGlide ETS - 00850012760054 Catalog Number :

Device Description : The CrossGlide Endometrial Tissue Sampler (ETS) is comprised of a Delivery Cathe The CrossGlide Endometrial Tissue Sampler (ETS) is comprised of a Delivery Catheter with a 6 Fr Biopsy Device and evertingmembrane that accesses the cervix and uterine cavity and a 3cc syringe with an attachable compliant tube assembly for supplyingsaline to the Delivery Catheter. The 3cc syringe is also used for supplying negative pressure in the ETS. The Delivery Cathetercontains an acorn tip as an aid in seating its distal end at the exocervix.

Device Class :

Duns Number: 065552991

Premarket Exempt : No

Product Code : HHK

Prescription Use : Yes

Device Count : 1

CrossGlide - 00850012760061 Catalog Number : CBPN3003

Device Description : The CrossGlide Endometrial Tissue Sampler (ETS Plus) is comprised of a Delivery The CrossGlide Endometrial Tissue Sampler (ETS Plus) is comprised of a Delivery Catheter with a 6 Fr Biopsy Device and evertingmembrane that accesses the cervix and uterine cavity and a 3cc syringe with an attachable compliant tube assembly for supplyingsaline to the Delivery Catheter. The 3cc syringe is also used for supplying negative pressure in the ETS. The Delivery Cathetercontains an acorn tip as an aid in seating its distal end at the exocervix.

Device Class : 2

Duns Number: 065552991

Premarket Exempt : No

Product Code : HHK

Prescription Use : Yes

Device Count : 1

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