FDA.reportPublic FDA data

Malibu

Primary DI
06974213565783
Brand
Malibu
Company
WENZHOU TIDE-OPTICAL CO.,LTD
Model
6223
Device description
Sunglasses, PC material, Ready-to wear type(51-21-140)
Published
2026-04-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
HDYDilator, Cervical, Hygroscopic-Laminaria

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDYDilator, Cervical, Hygroscopic-LaminariaObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16974213560488PackageGS112In Commercial Distribution
26974213560133PackageGS125In Commercial Distribution
06974213565783PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697421356048816974213560488
2697421356013326974213560133
06974213565783069742135657836974213565783

GMDN Terms#

Term, Definition table
TermDefinition
Tinted non-prescription spectaclesAn optical device, commonly known as sunglasses, that consists of a spectacle frame or clips with a pair of tinted spectacle lenses (typically made of plastic or glass) designed to be worn in front of the eyes to attenuate light radiation by absorption, reflection, or polarization to protect the eyes from bright light; it is neither intended to provide refractive corrections nor enhance colour discrimination.

Regulatory Flags#

DUNS number
539961200
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974213566148Malibu62232026-07-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
GYNX161031LaminariaGYNEX CORPORATIONHDY2017-01-19
GYNX161041LaminariaGYNEX CORPORATIONHDY2017-01-19
GYNX161051LaminariaGYNEX CORPORATIONHDY2017-01-19
00888937003307DilateriaCoopersurgical, Inc.HDY2016-09-20
00888937003314DilateriaCoopersurgical, Inc.HDY2016-09-20
00888937003321DilateriaCoopersurgical, Inc.HDY2016-09-20
00888937003338DilateriaCoopersurgical, Inc.HDY2016-09-20
60888937003309DilateriaCoopersurgical, Inc.HDY2016-09-20
60888937003316DilateriaCoopersurgical, Inc.HDY2016-09-20
60888937003323DilateriaCoopersurgical, Inc.HDY2016-09-20
60888937003330DilateriaCoopersurgical, Inc.HDY2016-09-20
M803021002MedGyn LaminariaMEDGYN PRODUCTS, INC.HDY2016-08-29
M803021003MedGyn LaminariaMEDGYN PRODUCTS, INC.HDY2016-08-29
M803021004MedGyn LaminariaMEDGYN PRODUCTS, INC.HDY2016-08-29
M803021005MedGyn LaminariaMEDGYN PRODUCTS, INC.HDY2016-08-29
M803021006MedGyn LaminariaMEDGYN PRODUCTS, INC.HDY2016-08-29
M803021008MedGyn LaminariaMEDGYN PRODUCTS, INC.HDY2016-08-29
M803021010MedGyn LaminariaMEDGYN PRODUCTS, INC.HDY2016-08-29
M803021014MedGyn LaminariaMEDGYN PRODUCTS, INC.HDY2016-08-29
M803021015MedGyn LaminariaMEDGYN PRODUCTS, INC.HDY2016-08-29
M803021016MedGyn LaminariaMEDGYN PRODUCTS, INC.HDY2016-08-29
M803021018MedGyn LaminariaMEDGYN PRODUCTS, INC.HDY2016-08-29
M803021022MedGyn LaminariaMEDGYN PRODUCTS, INC.HDY2016-08-29
M803021023MedGyn LaminariaMEDGYN PRODUCTS, INC.HDY2016-08-29
M803021024MedGyn LaminariaMEDGYN PRODUCTS, INC.HDY2016-08-29
M803021025MedGyn LaminariaMEDGYN PRODUCTS, INC.HDY2016-08-29
M803021026MedGyn LaminariaMEDGYN PRODUCTS, INC.HDY2016-08-29