FDA.reportPublic FDA data

KeraNetics

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30159804933015980493KERANETICS, INC.1N2026-01-01200 E 1st St Ste 102 Po Box 1 Winston Salem NC US 27101

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
B789P00100KeraStat Gel - Sterile, non-implantable, water-based gelatinous (hydrogel) wound dressing(336)725-0621info@keranetics.com
B789P00200KeraStat Cream - Non-sterile, non-implantable wound dressing(336)725-0621info@keranetics.com
B789P00210KeraStat Cream - Non-sterile, non-implantable wound dressing(336)725-0621info@keranetics.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2349741785706095K192386KeraStat CreamKGN2020-07-16
2349741309872740K162759KeraStat(R) GelKGN2017-06-02

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KGN22020-07-16

PMN#

GUDID#