FDA.reportPublic FDA data

BCG MEDICAL, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30093808953009380895BCG MEDICAL, LLC1Y2026-01-0123052 Andria Place Laguna Niguel CA US 92677

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00868680000303Opt-Shield - Non sterile single use OR table drape with warm air circulating and safe patient positioning capabilities.858-939-6272Rafael.Cruz@sharp..com
00868680000303Opt-Shield - Non sterile single use OR table drape with warm air circulating and safe patient positioning capabilities.904-716-4687LaShawn.Johnson@bmcjax.com
00868680000303Opt-Shield - Non sterile single use OR table drape with warm air circulating and safe patient positioning capabilities.813-888-1956Cecelia.Williams@baycare.org
00868680000310Opt-Shield Air Supine - Non sterile single use OR table drape with forced-air warming and safe patient positioning capabilities.858-939-6272Rafael.Cruz@sharp..com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1334271093125250K162562OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMYDWJ2017-03-17
1334271026864935
1334271027482183
1334271347151019
1334271561102428
1334271863944590

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DWJ12017-03-17

PMN#

GUDID#