Baylis Médicale Cie Inc

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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

Catheter, Septostomy (DXF) (6) Suture, Nonabsorbable, Synthetic, Polyethylene (GAT) (4)

Premarket Exempt

No Yes

Clear

NRG Transseptal Needle - 00685447000204 Catalog Number :

Device Class : 2

Duns Number: 249225954

Premarket Exempt : No

Product Code : DXF

Prescription Use : Yes

Device Count : 1

NRG Transseptal Needle - 00685447000211 Catalog Number :

Device Class : 2

Duns Number: 249225954

Premarket Exempt : No

Product Code : DXF

Prescription Use : Yes

Device Count : 1

NRG Transseptal Needle - 00685447000228 Catalog Number :

Device Class : 2

Duns Number: 249225954

Premarket Exempt : No

Product Code : DXF

Prescription Use : Yes

Device Count : 1

NRG Transseptal Needle - 00685447000235 Catalog Number :

Device Class : 2

Duns Number: 249225954

Premarket Exempt : No

Product Code : DXF

Prescription Use : Yes

Device Count : 1

NRG Transseptal Needle - 00685447000242 Catalog Number :

Device Class : 2

Duns Number: 249225954

Premarket Exempt : No

Product Code : DXF

Prescription Use : Yes

Device Count : 1

NRG Transseptal Needle - 00685447000259 Catalog Number :

Device Class : 2

Duns Number: 249225954

Premarket Exempt : No

Product Code : DXF

Prescription Use : Yes

Device Count : 1

AnchorKnot Suture - 00685447000396 Catalog Number :

Device Description : Cut Length, White/Blue Co-braid, Polyethylene/Polypropylene, Non-Absorbable Sutu

Device Class : 2

Duns Number: 249225954

Premarket Exempt : No

Product Code : GAT

Prescription Use : Yes

Device Count : 1

AnchorKnot Suture - 00685447000402 Catalog Number :

Device Description : Reel, White/Blue Co-braid, Polyethylene/Polypropylene, Non-Absorbable Suture, Me

Device Class : 2

Duns Number: 249225954

Premarket Exempt : No

Product Code : GAT

Prescription Use : Yes

Device Count : 1

AnchorKnot Suture - 00685447000419 Catalog Number :

Device Description : Cut Length, White Braided, Polyethylene, Non-Absorbable Suture, Meets USP except

Device Class : 2

Duns Number: 249225954

Premarket Exempt : No

Product Code : GAT

Prescription Use : Yes

Device Count : 1

AnchorKnot Suture - 00685447000426 Catalog Number :

Device Description : Reel, White Braided, Polyethylene, Non-Absorbable Suture, Meets USP except for o

Device Class : 2

Duns Number: 249225954

Premarket Exempt : No

Product Code : GAT

Prescription Use : Yes

Device Count : 1

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