FDA.report

EMSRUN

Primary DI
06974567745107
Brand
EMSRUN
Company
Wuxi Emsrun Technology Co., Ltd.
Model
CR-TH01
Published
2022-12-07
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
true

Related Records

Product Codes

CodeName
EFWToothbrush, Manual

Product Code Classifications

CodeDeviceSpecialtyClass
EFWToothbrush, ManualDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06974567745107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06974567745107069745677451076974567745107

GMDN Terms

TermDefinition
Assistive manual toothbrush, reusableAn instrument designed to be used by a disabled person to manually brush clean their teeth and gums (i.e., remove plaque, tartar, stains). It typically consists of a proximal handle and distal head to which is attached two or more rows of bristles (e.g., nylon) grouped in separate tufts, in rows, or evenly distributed; it may be designed with a grip adapted as an extension of the arm, hand, or finger. The device is normally used with toothpaste. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
542972552
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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 DIBrandModelCatalogPublished
06974567744704EMSRUNPZJD0020-22022-12-13
16974567747511RHINO RESCUECPDJ00052024-11-12
16974567747528RHINO RESCUECPHW00222024-10-24
16974567747771RHINO RESCUECP00252024-10-14
16974567747795RHINO RESCUECP00262024-10-14
16974567747535RHINO RESCUEPZZX00722024-10-12
06974567746630RHINO RESCUECPHW00022024-01-08
16974567748297Rhino RescuePZXF00012022-12-12
16974567749584Rhino RescueTJTK04022022-12-08
06974567749594Rhino RescueTJTK04072022-12-08
06974567749600Rhino RescueTJTK04062022-12-08
06974567749617Rhino RescueTJTK04052022-12-08
06974567749624Rhino RescueTJTK04042022-12-08
16974567749645Rhino RescueTJTK04032022-12-08
16974567749652Rhino RescueTJTK04012022-12-08
16974567749669Rhino RescueTJIK00062022-12-08
16974567749676Rhino RescueTJIK00052022-12-08
16974567749683Rhino RescueTJIK00042022-12-08
16974567749690Rhino RescueTJIK00032022-12-08
16974567749706Rhino RescueTJIK00022022-12-08

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00817169029892Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEFW2026-03-05
00810126504371Dream by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEFW2025-12-16
10884392008427Safety 1stDOREL JUVENILE GROUP, INC.EFW2025-12-15
10889483563403BALLARD™SUNMED, LLCEFW2025-12-01
10070942007365GUM Technique Sensitive CleanSUNSTAR AMERICAS, INC.EFW2025-08-15
10070942007419GUM Technique Sensitive CleanSUNSTAR AMERICAS, INC.EFW2025-08-15
20070942008093GUM Technique Sensitive CleanSUNSTAR AMERICAS, INC.EFW2025-08-15
10855424008487Freshen-UpMKJ Brands Limited Liability CompanyEFW2025-08-01
00304040192474Henry ScheinHENRY SCHEIN, INC.EFW2025-07-08
00194346458844EquateWAL-MART STORES, INC.EFW2025-07-07
06935883900014UbbiHuizhou LVB Maternal & Infant Supplies Co., Ltd.EFW2025-06-16
06935883900021UbbiHuizhou LVB Maternal & Infant Supplies Co., Ltd.EFW2025-06-16
06935883900038UbbiHuizhou LVB Maternal & Infant Supplies Co., Ltd.EFW2025-06-16
06935883900045UbbiHuizhou LVB Maternal & Infant Supplies Co., Ltd.EFW2025-06-16
06935883900052UbbiHuizhou LVB Maternal & Infant Supplies Co., Ltd.EFW2025-06-16
06935883900069UbbiHuizhou LVB Maternal & Infant Supplies Co., Ltd.EFW2025-06-16
06935883900076UbbiHuizhou LVB Maternal & Infant Supplies Co., Ltd.EFW2025-06-16
06935883900083UbbiHuizhou LVB Maternal & Infant Supplies Co., Ltd.EFW2025-06-16
06935883900090UbbiHuizhou LVB Maternal & Infant Supplies Co., Ltd.EFW2025-06-16
06935883900106UbbiHuizhou LVB Maternal & Infant Supplies Co., Ltd.EFW2025-06-16
00810180842044DynaCare Kids, Kids Toothbrushes, Assorted Colors, Soft Nylon Bristles Dynarex CorporationEFW2025-06-02
00072239331057Dr. Brown'sDr. Brown's CompanyEFW2025-05-23
00072239330418Dr. Brown'sDr. Brown's CompanyEFW2025-05-22
20070942006372GUM Technique Sensitive CleanSUNSTAR AMERICAS, INC.EFW2025-05-19
20070942008109GUM Technique Sensitive CleanSUNSTAR AMERICAS, INC.EFW2025-05-19
20070942008116GUM Technique Deep CleanSUNSTAR AMERICAS, INC.EFW2025-05-19
20810063756240KIDS BUDDY ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
20810063756257Power Curve ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
20810063756264Esprit Ultra Fine ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
20810063756271Whisper Tech Ultra-Fine ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19