BCG MEDICAL, LLC

Address:23052 Andria Place,Laguna Niguel,CA,92677,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

System, Thermal Regulating (DWJ) (2)

Premarket Exempt

Clear

Opt-Shield - 00868680000303 Catalog Number : OSA96X39LIT

Device Description : Non sterile single use OR table drape with warm air circulating and safe patient Non sterile single use OR table drape with warm air circulating and safe patient positioning capabilities.

Device Class :

Duns Number: 968666839

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Opt-Shield Air Supine - 00868680000310 Catalog Number : OSA90X39SUP

Device Description : Non sterile single use OR table drape with forced-air warming and safe patient p Non sterile single use OR table drape with forced-air warming and safe patient positioning capabilities.