FDA.reportPublic FDA data

Silicone Palm Teether

Primary DI
09420060210057
Brand
Silicone Palm Teether
Company
THINK GREEN LIMITED
Model
BHK062
Published
2024-12-17
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
09420060210057PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09420060210057094200602100579420060210057

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
595005923
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09420060215045haakaaBHK1732026-09-21
09420060215052haakaaBHK1792026-09-21
09420060215083haakaaBHK184-S2026-09-21
09420060215090haakaaBHK184-M2026-09-21
09420060215106haakaaBHK184-L2026-09-21
09420060215113haakaaBHK185-S2026-09-21
09420060215120haakaaBHK185-M2026-09-21
09420060215137haakaaBHK185-L2026-09-21
09420060216011haakaaAMZ1942026-09-21
09420060216028haakaaAMZ2052026-09-21
09420060216035haakaaGBHK1232026-09-21
09420060201055haakaaGBHK011-W2026-09-18
09420060201062haakaaGBHK011-R2026-09-18
09420060201079haakaaGBHK011-B2026-09-18
09420060201086haakaaGBHK011-V2026-09-18
09420060201093haakaaGBHK011-O2026-09-18
09420060201680haakaaMHK039-G-EX2026-09-18
09420060201697haakaaGBHK023-R2026-09-18
09420060201703haakaaGBHK1242026-09-18
09420060201710haakaaGBHK1252026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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