FDA.reportPublic FDA data

SHARN, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10358451035845SHARN, INC.1N2020-04-256850 Southbelt Dr SE Caledonia MI US 49316

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
00817518020129Sharn Inc - PATIENT EYE PROTECTOR 100/CASE800-325-3671mailbox@sharn.com
00817518022109Sharn Inc - EyeGard+1(800)325-3671mailbox@sharn.com
00817518022123Sharn Inc - EyeGard Extended Wear+1(800)325-3671mailbox@sharn.com
00817518022147Sharn Inc - EyeGard Sensitive+1(800)325-3671mailbox@sharn.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
284711675472021K984528PARKER FLEX-TIP TRACHEAL TUBEBTR1999-07-15
284711359989941K971229CAPNOXYGEN MASKCCK1997-09-23
284711536055819K955461TRANSTRACHEAL CATHETER (ACC. RAVUSSIN).BTO1997-03-19
284711074705639K954282ULTRACUFF BLOOD PRESSURE CUFF AND INFLATION BAGDXQ1996-02-06
284711252268605K940214STATCORP INC. DISPOSABLE BLOOD PRESSURE CUFFDXQ1994-02-22
284711148103416K921695ULTRA COVER ULTRASOUND TRANSDUCER PROBE COVERSITX1995-02-23
284711257441572K771464MULTISTAT III GLUCOSE TESTCFR1977-09-02
284711053924890K130097MEDMATE TRANSFER ADAPTER AM5500 & AM5500-NSFMI2014-07-22
284711579342973K091111RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI ADAPTER KIT-SINGLE PATIENT USE, MODEL RTCCAF2009-12-02
284711564688334K090361REMOTE INFRARED THERMOMETER, MODEL RC002FLL2009-10-08
284711031569496
284711121871765
284711124564590
284711177333382
284711193424665
284711197406702
284711214047920
284711245365868
284711270067357
284711302476449
284711308189288
284711339928404
284711349844078
284711547072677
284711605857593
284711610742056
284711633580168
284711645616747
284711680822998
284711715740346
284711732155729
284711771772807
284711790954143
284711865204854
284711897224427
284711899137709
284711925681042
284711981446067
284711983292082
284711987515753

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DXQ21996-02-06
FMI12014-07-22
CAF12009-12-02
FLL12009-10-08
BTR11999-07-15
CCK11997-09-23
BTO11997-03-19
ITX11995-02-23
CFR11977-09-02

PMN#

GUDID#

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