FDA.reportPublic FDA data

FLEX OPERATING ROOM, INC

Matched from indexed company URL: FLEX OPERATING ROOM, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30129667003012966700FLEX OPERATING ROOM, INC1Y2026-01-015801 County Road 41 Farmington NY US 14425

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
00869653000221Dinamic OR Gerstner Double Wide Orange Cover Labeled A1-A8 - 2000A-B585-635-7260greg@gerstnermedical.com
00869653000238Dinamic OR Gerstner Double Wide Blue Cover Labeled B1-B8 - 2000B-B585-635-7260greg@gerstnermedical.com
00869653000245Dinamic OR Gerstner Triple Wide Orange Cover Labeled A1-A12 - 3000A-B585-635-7260greg@gerstenermedical.com
10869653000228Dinamic OR Gerstner Double Wide Orange Cover Labeled A1-A8 - 2000A-B585-635-7260greg@gerstnermedical.com
10869653000235Dinamic OR Gerstner Double Wide Blue Cover Labeled B1-B8 - 2000B-B585-635-7260greg@gerstnermedical.com
10869653000242Dinamic OR Gerstner Triple Wide Orange Cover Labeled A1-A12 - 3000A-B585-635-7260greg@gerstenermedical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1972411257542647K101598EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONFIGURATIONS)KKX2010-10-04
1972411138041813

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KKX12010-10-04

GUDID#