FDA.reportPublic FDA data

CODONICS, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
15309581000639866CODONICS, INC.1Y2026-01-0117991 Englewood Dr Middleburg Heights OH US 44130

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
00814905020335Codonics Virtua® XR Medical Disc Publisher - Integrated Virtua XR DICOM Server & Medical Disc (CD/DVD) Publisher System4402431198support@codonics.com
00814905020427Codonics Virtua® C Controller - 92C - Virtua C/E DICOM Server/Publisher Controller -92C4402431198support@codonics.com
00814905021103Codonics Safe Label System®(SLS) 600i Point of Care Station - 170C - Safe Label System automated barcode scan and labeling RFID CoAx ready 170C4402431334support@codonics.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
524371190049468K962364CODONICS MEDICAL PRINTER (NP-1600M,NP1600MD)LMC1996-11-08
524371090113907K251352Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration)BSZ2025-07-11
524371257653574K101439CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500PBSZ2011-02-07
524371768035248K060440CODONICS HORIZON XL DIGITAL DIRECT LONG FILM IMAGER; CODONICS HORIZON XL-X LONG FILM IMAGERLMC2006-03-16
524371894711402K030690CODONICS EP-1000 MEDICAL COLOR DRY IMAGERSLMC2003-04-30
524371121367598K021054CODONICS HORIZON CI MEDICAL MULTIMEDIA DRY IMAGER; CODONICS HORIZON GS MEDICAL MULTIMEDIA GREY SCALE DRY IMAGERLMC2002-05-09
524371045691560K003481CODONICS NP-1660 SERIES MEDICAL PRINTERS, MODEL 1660LMC2001-01-19
524372062422131
524371312699298
524371321984876
524371846468655
524371889767700

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LMC52006-03-16
BSZ22025-07-11

PMN#

GUDID#

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