FDA.report

ENGLEWOOD

Primary DI
00840216118249
Brand
ENGLEWOOD
Company
Asp Global, LLC
Model
ENGLWD1
Device description
AMENITY KIT, ENGLEWOOD 1/BG, 20/CS
Published
2022-08-26
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

Related Records

Product Codes

CodeName
EFWToothbrush, Manual

Product Code Classifications

CodeDeviceSpecialtyClass
EFWToothbrush, ManualDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840216118249PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840216118249008402161182498402161182490840216118249

GMDN Terms

TermDefinition
Basic manual toothbrushAn instrument designed to be used by a patient to manually brush clean their teeth and gums (i.e., remove plaque, tartar, stains). It typically consists of a proximal handle and distal head with rows of bristles (e.g., nylon) grouped in separate tufts or evenly distributed. The device is typically used with toothpaste. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
080361159
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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 DIBrandModelCatalogPublished
00840216128262ASP GLOBALEGT3052025-11-20
00840216128286ASP GLOBALEGT3072025-11-20
00840216128804ASP GLOBAL PRIMOAFTS012025-06-30
00840216128279ASP GLOBALEGT3062025-06-17
00840216128293ASP GLOBALEGT3082025-06-17
00840216128842CARDINAL HEALTH AD6X10BILH2025-06-17
00840216128606LAPCORP LC4X6EZQ2025-05-13
00840216128613LAPCORP LC9X12MTL2025-05-13
00840216128163QUEST DIAGNOSTICSQD6.75X11AD2024-11-22
00840216127753ASP MEDICALMRT8002024-09-12
00840216128033ASP MEDICALMRACUP12024-09-12
20840216127566PRIMOAFTMATT2024-08-12
00840216120808PRIMOGGS3660TBH-K2024-03-05
00840216120853PRIMOGGS5670TBH-K2024-03-05
00840216121898PRIMOGGTS142024-03-05
00840216124509PRIMOGGTS13-K2024-03-05
00840216124516PRIMOGGTS14-5-K2024-03-05
00840216122697PRIMOAFPUMP2024-03-01
00840216125124PRIMOHB2002024-03-01
00840216125131PRIMOHB200B2024-03-01

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