FDA.reportPublic FDA data

Ceramix mat M1

Primary DI
08800132500001
Brand
Ceramix mat M1
Company
HANILMEDICAL CO.,LTD.
Model
CGM EMT-MS1601
Published
2021-06-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
IRTPad, Heating, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRTPad, Heating, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800132500001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800132500001088001325000018800132500001

GMDN Terms#

Term, Definition table
TermDefinition
Electric pad localized-body heating systemAn assembly of mains electricity (AC-powered) devices designed for the transcutaneous application of heat to a localized body site (e.g., joint, limb) to relieve musculoskeletal pain. It consists of an electric heating pad typically made of synthetic fabric materials, and a hand-held control unit used to regulate and monitor the heat. It is intended for use in the home or a clinical setting.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
687625082
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800132500018Ceramix mat S1CGM EMT-SS16072021-06-22
08800132500025HEALAX i ShoulderCGM ESA-SD15012021-06-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00024291256076HANDY SOLUTIONS HEATING PAD WRAP SHOULDER AND NECKNavajo Manufacturing CompanyIRT2026-01-29
00087453001662HygenicHYGENIC CORPORATION, THEIRT2026-01-13
00087453001679HygenicHYGENIC CORPORATION, THEIRT2026-01-13
10041298995040DMID-M-S HOLDINGS, INC.IRT2025-12-30
06950940802827N/AShenzhen Osto Technology Co.,Ltd.IRT2025-12-20
00053891181952SunbeamJarden Consumer SolutionsIRT2025-12-03
10810140062298iDOO Heating PadJoicom CorporationIRT2025-08-29
00846841092596mibestBeijing Choice Electronic Technology Co., Ltd.IRT2025-07-23
00860163001517BIOMAT QUEENRICHWAY & FUJI BIO INC.IRT2025-06-16
00860163001524BIOMAT PROFESSIONALRICHWAY & FUJI BIO INC.IRT2025-06-16
00860163001531BIOMAT SINGLERICHWAY & FUJI BIO INC.IRT2025-06-16
00860163001548BIOMAT MINIRICHWAY & FUJI BIO INC.IRT2025-06-16
00860163001555BIO-BELTRICHWAY & FUJI BIO INC.IRT2025-06-16
10041298991967DMID-M-S HOLDINGS, INC.IRT2025-06-12
00199284161986Berkshire Blanket & Home Co. Inc.Berkshire Blanket & Home Co., Inc.IRT2025-06-01
00199284703056Berkshire Blanket & Home Co. Inc.Berkshire Blanket & Home Co., Inc.IRT2025-06-01
00199284943056Berkshire Blanket & Home Co. Inc.Berkshire Blanket & Home Co., Inc.IRT2025-06-01
00311917052458WalgreensWALGREEN CO.IRT2025-05-30
088095244965333H3H, Co., LtdIRT2025-05-30
088095244965953H3H, Co., LtdIRT2025-05-30
088095244966703H3H, Co., LtdIRT2025-05-30
00810140062147RENPHO Heating PadJoicom CorporationIRT2025-05-29
00810140062154RENPHO Heating PadJoicom CorporationIRT2025-05-29
00810140062161RENPHO Heating PadJoicom CorporationIRT2025-05-29
00810140062178RENPHO Heating PadJoicom CorporationIRT2025-05-29
00810140062192iDOO Heating PadJoicom CorporationIRT2025-05-29
00810140062208iDOO Heating PadJoicom CorporationIRT2025-05-29
00810140062215iDOO Heating PadJoicom CorporationIRT2025-05-29
00810140062222iDOO Heating PadJoicom CorporationIRT2025-05-29
00810140062246RENPHO Heating PadJoicom CorporationIRT2025-05-29