C. R. Bard, Inc.

Address:1211 MARY MAGNAN BLVD.,MADISON,GA,30650,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

ELECTRODE, PACEMAKER, TEMPORARY (LDF) (7) CATHETER, COUDE (EZC) (1) CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES (MJC) (1) DILATOR, URETHRAL (KOE) (1)

Premarket Exempt

No Yes

Clear

Bardex® I.C. Complete Care® Foley Tray - 00801741000263 Catalog Number : 300016A

Device Description : Bardex® I.C. Complete Care® Foley Tray

Device Class : 2

Duns Number: 016898496

Premarket Exempt : No

Product Code : MJC

Prescription Use : Yes

Device Count : 1

Bard® Foley Tray with Bardex® Lubricath® Foley Catheter - 00801741000287 Catalog Number : 899616

Device Description : Bard® Foley Tray with Bardex® Lubricath® Hydrophilic-Coated Foley Catheter

Device Class : 2

Duns Number: 016898496

Premarket Exempt : No

Product Code : EZC

Prescription Use : Yes

Device Count : 1

Bard® Urologist's Tray - 00801741000294 Catalog Number : 123400

Device Description : Bard® Urologist's Tray

Device Class : 2

Duns Number: 016898496

Premarket Exempt : Yes

Product Code : KOE

Prescription Use : Yes

Device Count : 1

N/A - 00801741011191 Catalog Number : 006172P

Device Description : Balloon Bipolar Temporary Pacing Electrode Catheter, Stainless Steel Electrodes

Device Class : 2

Duns Number: 016898496

Premarket Exempt : No

Product Code : LDF

Prescription Use : Yes

Device Count : 1

N/A - 00801741011207 Catalog Number : 006173P

Device Description : Balloon Bipolar Temporary Pacing Electrode Catheter, Stainless Steel Electrodes

Device Class : 2

Duns Number: 016898496

Premarket Exempt : No

Product Code : LDF

Prescription Use : Yes

Device Count : 1

N/A - 00801741011214 Catalog Number : 006221P

Device Description : Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes

Device Class : 2

Duns Number: 016898496

Premarket Exempt : Yes

Product Code : LDF

Prescription Use : Yes

Device Count : 1

N/A - 00801741011221 Catalog Number : 006225P

Device Description : Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes

Device Class : 2

Duns Number: 016898496

Premarket Exempt : Yes

Product Code : LDF

Prescription Use : Yes

Device Count : 1

N/A - 00801741011238 Catalog Number : 006241P

Device Description : Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes

Device Class : 2

Duns Number: 016898496

Premarket Exempt : Yes

Product Code : LDF

Prescription Use : Yes

Device Count : 1

N/A - 00801741011245 Catalog Number : 006242P

Device Description : Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes

Device Class : 2

Duns Number: 016898496

Premarket Exempt : Yes

Product Code : LDF

Prescription Use : Yes

Device Count : 1

N/A - 00801741011252 Catalog Number : 006395P

Device Description : Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes

Device Class : 2

Duns Number: 016898496

Premarket Exempt : Yes

Product Code : LDF

Prescription Use : Yes

Device Count : 1

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