Em Device Lab, Inc

Address:6303 Mountain Park Cv,Austin,TX,78731,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, Irrigation (GBX) (1)

Premarket Exempt

Yes

Clear

Quickloop Abscess Treatment Device - B762M01000010 Catalog Number : M01-0-0005

Device Description : Device for draining and irrigating cutaneous and oral fluid collections such as Device for draining and irrigating cutaneous and oral fluid collections such as abscesses, seromas and hematomas.

Device Class : 1

Duns Number: 080664372

Premarket Exempt : Yes

Product Code : GBX

Prescription Use : Yes

Device Count : 1

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