PECO MEDICAL 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, URETHRAL (GBM) (9)

Premarket Exempt

Clear

PECO - 10817668010114 Catalog Number :

Device Description : Box PECO™ 7.5" Female, 18 Fr. Straight Intermittent Catheter

Device Class :

Duns Number: 080120792

Premarket Exempt : No

Product Code : GBM

Prescription Use : No

Device Count : 30

PECO - 10817668010121 Catalog Number :

Device Description : Box PECO™ 7.5" Female, 8 Fr. Straight Intermittent Catheter

Device Class :

Duns Number: 080120792

Premarket Exempt : No

Product Code : GBM

Prescription Use : No

Device Count : 30

PECO - 10817668010503 Catalog Number :

Device Description : Box PECO™ 10" Pediatric, 6 Fr. Straight Intermittent Catheter

Device Class :

Duns Number: 080120792

Premarket Exempt : No

Product Code : GBM

Prescription Use : No

Device Count : 30

PECO - 10817668010510 Catalog Number :

Device Description : Box PECO™ 16" Male, 6 Fr. Straight Intermittent Catheter

Device Class :

Duns Number: 080120792

Premarket Exempt : No

Product Code : GBM

Prescription Use : No

Device Count : 30

PECO - 10817668010527 Catalog Number :

Device Description : Box PECO™ 16" Male, 8 Fr. Straight Intermittent Catheter

Device Class :

Duns Number: 080120792

Premarket Exempt : No

Product Code : GBM

Prescription Use : No

Device Count : 30

PECO - 10817668010534 Catalog Number :

Device Description : Box PECO™ 16" Male, 10 Fr. Straight Intermittent Catheter

Device Class :

Duns Number: 080120792

Premarket Exempt : No

Product Code : GBM

Prescription Use : No

Device Count : 30

PECO - 10817668010558 Catalog Number :

Device Description : Box PECO™ 10" Pediatric, 12 Fr. Straight Intermittent Catheter

Device Class :

Duns Number: 080120792

Premarket Exempt : No

Product Code : GBM

Prescription Use : No

Device Count : 30

PECO - 10817668010565 Catalog Number :

Device Description : Box PECO™ 10" Pediatric, 14 Fr. Straight Intermittent Catheter

Device Class :

Duns Number: 080120792

Premarket Exempt : No

Product Code : GBM

Prescription Use : No

Device Count : 30

PECO - 10817668010572 Catalog Number :

Device Description : Box PECO™ 7.5" Female, 14 Fr. Straight Intermittent Catheter

Device Class :

Duns Number: 080120792

Premarket Exempt : No

Product Code : GBM

Prescription Use : No

Device Count : 30

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