FDA.reportPublic FDA data

GRAFCO

Primary DI
M36883761
Brand
GRAFCO
Company
GF HEALTH PRODUCTS, INC.
Model
8376
Device description
Stainless Steel Sterilizer, Dry Heat
Published
2020-08-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KMHSterilizer, Dry Heat

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMHSterilizer, Dry HeatGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K771070000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K771070000DRY HEAT STERILIZERCpac, Inc.1977-07-14KMH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M36883761PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dry-heat sterilizerA mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from non-heat sensitive medical devices and related products using dry heat sterilization. It typically includes a treatment chamber with shelves where the devices to be sterilized are placed, usually after cleaning of gross debris; a heat source (e.g., electric heaters); and controls to regulate the time and/or temperature of the procedure. The heat may flow into the chamber either by natural convection or using forced air to accelerate and/or make more uniform the process (e.g., fans, high-speed hot air jets). The device is available in stand-alone (bulk) and tabletop units.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
770-368-4700cs@grahamfield.com

Regulatory Flags#

DUNS number
132016168
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M368EPC500ST1HAUSTEDEPC500ST2026-04-09
M368EPC500STMB1HAUSTEDEPC500ST-MB2026-04-09
M3681097001GRAHAM FIELD109-7002026-02-20
M36812731Grafco127312732020-10-01
M36812751Grafco127512752020-10-01
M3684001GF1GRAFCO4001GF4001GF2020-04-01
M3684002GF1GRAFCO4002GF4002GF2020-04-01
M3682362X1GRAHAM FIELD2362X2026-02-20
M3681097002GRAHAM FIELD109-7002026-02-20
M3682338A1GRAHAM FIELD2338A 2026-02-20
M3682338X1GRAHAM FIELD2338X2026-02-20
M36823452A1GRAHAM FIELD2345-2A2026-02-20
M36823452C1GRAHAM FIELD2345-2C 2026-02-20
M36823452X1GRAHAM FIELD2345-2X2026-02-20
M36823481A1GRAHAM FIELD2348-1A 2026-02-20
M36823552N1GRAHAM FIELD2355-2N 2026-02-20
M36823552X1GRAHAM FIELD2355-2X 2026-02-20
M36823562A1GRAHAM FIELD2356-2A 2026-02-20
M36823562C1GRAHAM FIELD2356-2C 2026-02-20
M36823562N1GRAHAM FIELD2356-2N 2026-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B234KMHRHPRO111230V1RH-Pro11-230VCPAC EQUIPMENT, INC.KMH2020-10-01
B234KMHRHPRO9115V3RH-Pro9CPAC EQUIPMENT, INC.KMH2020-10-01
B234KMHRHPRO9115V4RH-Pro9-230VCPAC EQUIPMENT, INC.KMH2020-10-01
M36883751GRAFCOGF HEALTH PRODUCTS, INC.KMH2020-08-24
B234KMHRHPRO111115V0RH-Pro11CPAC EQUIPMENT, INC.KMH2019-01-18
B234KMHSD201000115STERIDENTCPAC EQUIPMENT, INC.KMH2018-08-31
B234KMHSD201000230STERIDENTCPAC EQUIPMENT, INC.KMH2018-08-31
B234KMHSD301000115STERIDENTCPAC EQUIPMENT, INC.KMH2018-08-31
B234KMHSD301000230STERIDENTCPAC EQUIPMENT, INC.KMH2018-08-31
B234KMHCX6220230V152COX RAPIDHEATCPAC EQUIPMENT, INC.KMH2018-08-24
B234KMHCX6220230V163COX RAPIDHEATCPAC EQUIPMENT, INC.KMH2018-08-24
B234KMHSS2100115V2STERISURECPAC EQUIPMENT, INC.KMH2018-08-24
B234KMHSS2100230V0STERISURECPAC EQUIPMENT, INC.KMH2018-08-24
B234KMHSS3100115V3STERISURECPAC EQUIPMENT, INC.KMH2018-08-24
B234KMHSS3100230V1STERISURECPAC EQUIPMENT, INC.KMH2018-08-24
B234KMHCX6000115V161COX RAPIDHEATCPAC EQUIPMENT, INC.KMH2018-08-23
B234KMHCX6000115V150COX RAPIDHEATCPAC EQUIPMENT, INC.KMH2018-07-31
D661D5000SHT0DentronixDENTRONIX INCKMH2016-07-15
D661D5000ST0DentronixDENTRONIX INCKMH2016-07-15
D661D7000C0DentronixDENTRONIX INCKMH2016-07-15
D661D7000CL0DentronixDENTRONIX INCKMH2016-07-15
D661D7000F0DentronixDENTRONIX INCKMH2016-07-15
D661D7000MS0DentronixDENTRONIX INCKMH2016-07-15
D661D7000SILVER0DentronixDENTRONIX INCKMH2016-07-15
D661D7107010DentronixDENTRONIX INCKMH2016-07-15
D661DADBL0DentronixDENTRONIX INCKMH2016-07-15
D661DADUL0DentronixDENTRONIX INCKMH2016-07-15
D661DDS70001150DentronixDENTRONIX INCKMH2016-07-15
D661DDS70002300DentronixDENTRONIX INCKMH2016-07-15
D661DDS7000230K0DentronixDENTRONIX INCKMH2016-07-15