FDA.reportPublic FDA data

Baby Bristles Teether

Primary DI
00850036799504
Brand
Baby Bristles Teether
Company
Supermouth LLC
Model
501501018
Device description
Non-Fluid Filled
Published
2024-06-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MEFRing, Teething, Non-Fluid Filled

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEFRing, Teething, Non-Fluid FilledDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850036799504PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850036799504008500367995048500367995040850036799504

GMDN Terms#

Term, Definition table
TermDefinition
Infant care kitA portable collection of devices and supplies designed to assist in the care of an infant/baby that typically includes two or more of the following: a thermometer, medical measuring spoon/dropper, nasal aspirator, irrigation saline solution, a teether, and nail clippers. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
049384038
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810131045319Ultim8 Adult Ortho Sonic Rechargeable Toothbrush Pearly White 40000222025-12-02
00810131045326Ultim8 Adult Ortho Sonic Rechargeable Toothbrush Saphire Blue40000232025-12-02
00810131045333Ultim8 Adult Ortho Sonic Rechargeable Toothbrush Rose Gold40000242025-12-02
00810131044190Ultim8 Adult Rose Gold Sonic Rechargeable Toothbrush40000172025-06-30
00810131044725Adult SuperScraper Silver100000072025-06-30
00810131044732Adult SuperScraper Rose Gold100000082025-06-30
00850036799993Ultim8 Sonic Pearly White Toothbrush & UV Sanitizer Box Set 120000262025-06-30
00810131041502Adult Resuable Tongue Scraper 100000032025-05-25
00810131041519Ortho Resuable Tongue Scraper Silver100000042025-05-25
00810131041526Ortho Resuable Tongue Scraper Rose Gold100000052025-05-25
00810131040000Super Vanilla Ortho Floss Fluoride07002020562024-06-01
00810131040017Super StrawberryOrtho Floss Fluoride07002040562024-06-01
00810131040024Super Mint Ortho Floss Fluoride07002050562024-06-01
00810131040031Super Chocolate Ortho Floss Fluoride07002030562024-06-01
00810131040215Superbrush Bluetooth Brush Junior040000012024-06-01
00810131040222Superbrush Orange A Peel Brush Junior040000022024-06-01
00810131040239Superbrush Yellow Sunshine Brush Junior040000032024-06-01
00810131040246Superbrush Tangerine Clean Toothbrush040000042024-06-01
00810131040253Superbrush Breath Mint Toothbrush040000052024-06-01
00810131040260Superbrush Blue Biome Toothbrush040000062024-06-01

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Primary DI, Brand, Company table
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