PPMDM

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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

Trocar (DRC) (10)

Premarket Exempt

Clear

SafeSept Transseptal Guidwire - 00858769006104 Catalog Number : SS-135

Device Description : 0.014" Transseptal guidewire.

Device Class : 2

Duns Number: 081047841

Premarket Exempt : No

Product Code : DRC

Prescription Use : Yes

Device Count : 1

SafeSept Needle Free Transseptal Guidewire - 00858769006111 Catalog Number : SSNF

Device Description : 0.031" Transseptal guidewire.

Device Class : 2

Duns Number: 081047841

Premarket Exempt : No

Product Code : DRC

Prescription Use : Yes

Device Count : 1

Needle Free Transseptal Cannula - 00858769006135 Catalog Number : TSC071

Device Description : 71cm Transseptal Cannula Curve 0

Device Class : 2

Duns Number: 081047841

Premarket Exempt : No

Product Code : DRC

Prescription Use : Yes

Device Count : 1

Needle Free Transseptal Cannula - 00858769006142 Catalog Number : TSC089

Device Description : 89cm Transseptal Cannula Curve 0

Device Class : 2

Duns Number: 081047841

Premarket Exempt : No

Product Code : DRC

Prescription Use : Yes

Device Count : 1

Needle Free Transseptal Cannula - 00858769006159 Catalog Number : TSC098

Device Description : 98cm Transseptal Cannula Curve 0

Device Class : 2

Duns Number: 081047841

Premarket Exempt : No

Product Code : DRC

Prescription Use : Yes

Device Count : 1

Needle Free Transseptal Cannula - 00858769006166 Catalog Number : TSC171

Device Description : 71cm Transseptal Cannula Curve 1

Device Class : 2

Duns Number: 081047841

Premarket Exempt : No

Product Code : DRC

Prescription Use : Yes

Device Count : 1

Needle Free Transseptal Cannula - 00858769006173 Catalog Number : TSC189

Device Description : 89cm Transseptal Cannula Curve 1

Device Class : 2

Duns Number: 081047841

Premarket Exempt : No

Product Code : DRC

Prescription Use : Yes

Device Count : 1

Needle Free Transseptal Cannula - 00858769006180 Catalog Number : TSC198

Device Description : 98cm Transseptal Cannula Curve 1

Device Class : 2

Duns Number: 081047841

Premarket Exempt : No

Product Code : DRC

Prescription Use : Yes

Device Count : 1

Transseptal Needle - 00858769006197 Catalog Number : TSN071

Device Description : 71cm Transseptal Needle Curve 0

Device Class : 2

Duns Number: 081047841

Premarket Exempt : No

Product Code : DRC

Prescription Use : Yes

Device Count : 1

Transseptal Needle - 00858769006203 Catalog Number : TSN089

Device Description : 89cm Transseptal Needle Curve 0

Device Class : 2

Duns Number: 081047841

Premarket Exempt : No

Product Code : DRC

Prescription Use : Yes

Device Count : 1

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