FDA.reportPublic FDA data

Brasseler USA

Primary DI
00887919950158
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5028385U0
Device description
GEM20 X-RAY SENSOR STARTER KIT
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

Product Codes#

Code, Name table
CodeName
MUHSystem, x-ray, extraoral source, digital

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUHSystem, X-Ray, Extraoral Source, DigitalDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887919950158PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919950158008879199501588879199501580887919950158

GMDN Terms#

Term, Definition table
TermDefinition
Dental digital imaging sensor, intraoralAn analogue device that is temporarily placed in a patient's mouth to perform routine diagnostic dental imaging procedures. It uses analogue-to-digital conversion techniques to record the absorption pattern of x-ray beams used in the diagnosis and treatment of diseases of the jaw or oral cavity structures. The device is used in combination with the x-ray source (x-ray tube) that is located outside the patient's mouth during the imaging procedure; the resulting digital image is transmitted to a monitor or workstation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
082080136
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08404535019247Brasseler USA5031780U05031780U02026-03-24
08404535024906Brasseler USA5032029U05032029U02026-03-23
08404535024937Brasseler USA5032030U05032030U02026-03-23
08404535024968Brasseler USA5032031U05032031U02026-03-23
08404535025156LARGE BONE BLADESBR1-12100-50BR1-12100-502026-03-23
08404535024579Brasseler USAFL17CHP5032016U02026-03-17
08404535024609Brasseler USAFL17MHP5032017U02026-03-17
08404535024630Brasseler USAFL17FHP5032018U02026-03-17
08404535024661Brasseler USAFL17UF5032019U02026-03-17
08404535021769BrioPrep Sterile Diamonds5031856U05031856U02025-11-21
08404535021790BrioPrep Sterile Diamonds5031857U05031857U02025-11-21
08404535021820BrioPrep Sterile Diamonds5031858U05031858U02025-11-21
08404535021851BrioPrep Sterile Diamonds5031859U05031859U02025-11-21
08404535021882BrioPrep Sterile Diamonds5031860U05031860U02025-11-21
08404535021912BrioPrep Sterile Diamonds5031861U05031861U02025-11-21
08404535021943BrioPrep Sterile Diamonds5031862U05031862U02025-11-21
08404535021974BrioPrep Sterile Diamonds5031863U05031863U02025-11-21
08404535022001BrioPrep Sterile Diamonds5031864U05031864U02025-11-21
08404535022124BrioPrep Sterile Diamonds5031880U05031880U02025-11-21
08404535022155BrioPrep Sterile Diamonds5031881U05031881U02025-11-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D804W1203005DRT0X-MIND optima 3DDE GÖTZEN SRLMUH2026-03-23
D804W1203005FLDRT0X-MIND optima 3DDE GÖTZEN SRLMUH2026-03-23
D804W1203010DRT0X-MIND optima 3DDE GÖTZEN SRLMUH2026-03-23
D804W1203015DRT0X-MIND optima 3DDE GÖTZEN SRLMUH2026-03-23
D804W1203015FLDRT0X-MIND optima 3DDE GÖTZEN SRLMUH2026-03-23
D804W1203020DRT0X-MIND optima 3DDE GÖTZEN SRLMUH2026-03-23
08033837934981myrayCEFLA SOCIETA' COOPERATIVAMUH2026-03-13
08033837935001myrayCEFLA SOCIETA' COOPERATIVAMUH2026-03-13
08033837936091NewTomCEFLA SOCIETA' COOPERATIVAMUH2026-03-13
08033837936176CastelliniCEFLA SOCIETA' COOPERATIVAMUH2026-03-13
08033837936411CastelliniCEFLA SOCIETA' COOPERATIVAMUH2026-03-13
06970569090856Digital Intraoral X-ray Imaging SystemiRay GroupMUH2025-08-29
06970569090863Digital Intraoral X-ray Imaging SystemiRay GroupMUH2025-08-29
D178XR3800Flight Dental SystemsFlight Dental Systems USA Inc.MUH2025-08-29
08800003027088RAYSCAN α-PRay Co., LtdMUH2025-08-25
03760262650814Owandy RadiologyOWANDY RADIOLOGYMUH2025-05-15
D804W13000050U-SENSE HDDE GÖTZEN SRLMUH2025-05-15
08809244060199GenorayGENORAY CO., LTD.MUH2025-05-02
08809244060229GenorayGENORAY CO., LTD.MUH2025-05-02
08809244060236GenorayGENORAY CO., LTD.MUH2025-05-02
00304040190623Henry ScheinHENRY SCHEIN, INC.MUH2025-03-05
06941877815196EighteethChangzhou Sifary Medical Technology Co., Ltd.MUH2025-01-21
08033837936817myrayCEFLA SOCIETA' COOPERATIVAMUH2024-12-31
08033837936848NewTomCEFLA SOCIETA' COOPERATIVAMUH2024-12-31
08033837936855CastelliniCEFLA SOCIETA' COOPERATIVAMUH2024-12-31
08800016401950VistaPano S 2.0VATECH CO., LTD.MUH2024-12-13
08800016401967VistaPano S Ceph 2.0VATECH CO., LTD.MUH2024-12-13
D9021050013MISTER X RAYDental Savings Club IncMUH2024-12-12
03760262651606I-MAXOWANDY RADIOLOGYMUH2024-11-11
D804W1200001FL0X-MIND primeDE GÖTZEN SRLMUH2024-11-11