FDA.reportPublic FDA data

Brasseler USA

Primary DI
00887919684145
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5023628U0
Device description
FSSS4/12 MIRROR SIZE 4 12PACK
Published
2022-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EAXMIRROR, MOUTH

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EAXMirror, MouthDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887919684145PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919684145008879196841458879196841450887919684145

GMDN Terms#

Term, Definition table
TermDefinition
Dental mirror, reusableA hand-held, dental instrument intended to be used by a dentist for intraoral inspection or inspection and retraction. It typically consists of a stainless steel shaft terminating at the distal end in a small round mirror that is angled to the shaft. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
082080136
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887919683902Brasseler USA5023604U05023604U02026-07-13
08404535030761Brasseler USA5032375U05032375U02026-07-13
08404535030792Brasseler USA5032376U05032376U02026-07-13
08404535030822Brasseler USA5032378U05032378U02026-07-13
08404535018981Brasseler USA5031820U05031820U02026-06-26
08404535019018Brasseler USA5031821U05031821U02026-06-26
00887919170488Brasseler USA Sterile Carbide000388SP000388SP2026-05-27
00887919227335Brasseler USA Sterile Diamond004878SP004878SP2026-05-27
00887919317036Brasseler USA Sterile Diamond017274SP017274SP2026-05-27
08404535029468Brasseler USA Sterile Diamond004164SP004164SP2026-05-27
08404535029499Brasseler USA Sterile Diamond004325SP004325SP2026-05-27
08404535029529Brasseler USA Sterile Diamond004529SP004529SP2026-05-27
08404535029550Brasseler USA Sterile Diamond004801SP004801SP2026-05-27
08404535029581Brasseler USA Sterile Diamond004818SP004818SP2026-05-27
08404535029611Brasseler USA Sterile Diamond004820SP004820SP2026-05-27
08404535029642Brasseler USA Sterile Diamond004868SP004868SP2026-05-27
08404535029673Brasseler USA Sterile Diamond004959SP004959SP2026-05-27
08404535029703Brasseler USA Sterile Diamond005034SP005034SP2026-05-27
08404535029734Brasseler USA Sterile Diamond005043SP005043SP2026-05-27
08404535029765Brasseler USA Sterile Diamond005046SP005046SP2026-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456218341JMUJMU DENTAL, INCEAX2026-07-07
00840456218358JMUJMU DENTAL, INCEAX2026-07-07
00840456218365JMUJMU DENTAL, INCEAX2026-07-07
00840456218372JMUJMU DENTAL, INCEAX2026-07-07
00840456218389JMUJMU DENTAL, INCEAX2026-07-07
00840456218396JMUJMU DENTAL, INCEAX2026-07-07
08961104622579Dental Mouth Mirror MELPEX BEAUTY INSTRUMENTSEAX2026-05-21
08961104622586Dental Mouth MirrorMELPEX BEAUTY INSTRUMENTSEAX2026-05-21
08961104622944Dental Mouth MirrorMELPEX BEAUTY INSTRUMENTSEAX2026-05-21
G149TBSB3110TBS BASICSACME ENTERPRISE.EAX2026-05-16
G149TBSB3120TBS BASICSACME ENTERPRISE.EAX2026-05-16
G149TBSB3130TBS BASICSACME ENTERPRISE.EAX2026-05-16
G149TBSB3140TBS BASICSACME ENTERPRISE.EAX2026-05-16
1081000052669420/20™PARKELL, INC.EAX2025-09-26
M633680501B4JEDMEDJEDMED INSTRUMENT COMPANYEAX2023-02-03
10371347002550Mirror Front Surface Cone Socket #4The Atlanta Dental Supply CompanyEAX2022-11-23
10371347002567Mirror Front Surface Simple Stem #4The Atlanta Dental Supply CompanyEAX2022-11-23
10371347002574Mirror Front Surface Cone Socket #5The Atlanta Dental Supply CompanyEAX2022-11-23
10371347002581Mirror Front Surface Simple Stem #5The Atlanta Dental Supply CompanyEAX2022-11-23
10818207024203Vista RSS Mirror HandleVista DentalEAX2022-09-01
10818207024210Vista RCS Mirror HandleVista DentalEAX2022-09-01
10818207024227Vista OCS Mirror HandleVista DentalEAX2022-09-01
10843717102592Midway SelectMIDWAY DENTAL SUPPLY, LLCEAX2022-08-26
10843717102608Midway SelectMIDWAY DENTAL SUPPLY, LLCEAX2022-08-26
10843717102615Midway SelectMIDWAY DENTAL SUPPLY, LLCEAX2022-08-26
10843717102622Midway SelectMIDWAY DENTAL SUPPLY, LLCEAX2022-08-26
G1577072350PomeePOMEE CORPORATIONEAX2021-12-30
10889950015381HU-FRIEDYHU-FRIEDY MFG. CO., LLCEAX2020-11-12
10889950015398HU-FRIEDYHU-FRIEDY MFG. CO., LLCEAX2020-11-12
10889950015404HU-FRIEDYHU-FRIEDY MFG. CO., LLCEAX2020-11-12