ADAPTA MEDICAL INC

Address:142 Talamine Ct,Colorado Springs,CO,80907,US

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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

Catheter, Straight (EZD) (2) Catheter, Urethral (GBM) (1)

Premarket Exempt

Clear

n-Able Cath™ - 00851847007000 Catalog Number : 7025-2020

Device Description : n-Able Cath Hydro-Straight, Sterile, Single-Use 14 French Intermittent Urinary Catheter.

Device Class : 2

Duns Number: 836441613

Premarket Exempt : No

Product Code : GBM

Prescription Use : Yes

Device Count : 1

mPower Cath™ - 00851847007031 Catalog Number : 7020-1468

Device Description : mPower Cath™ Hydro-Straight Sterile, Single-Use 14 Fr Intermittent Urinary Catheter.

Device Class :

Duns Number: 836441613

Premarket Exempt : No

Product Code : EZD

Prescription Use : Yes

Device Count : 1

PerfIC Cath™ - 00851847007055 Catalog Number : 7020-1571

Device Description : PerfIC Cath™ Hydro-Straight, Sterile, Single-Use 14 French Intermittent Urinary Catheter.

Device Class :

Duns Number: 836441613

Premarket Exempt : No

Product Code : EZD

Prescription Use : Yes

Device Count : 1

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