FDA.reportPublic FDA data

Blinkeze

Primary DI
00813142021570
Brand
Blinkeze
Company
MEDDEV CORPORATION
Model
TEW6024-2
Catalog number
TEW6024-2
Device description
Blinkeze External Lid Weight, 2.4g, Tan
Published
2023-11-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
MMLWeights, Eyelid, External

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MMLWeights, Eyelid, ExternalOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K940974000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K940974000EYECLOSE EXTERNAL EYELID WEIGHTSMeddev Corp.1994-06-08MML

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813142021570PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813142021570008131420215708131420215700813142021570

GMDN Terms#

Term, Definition table
TermDefinition
Eyelid weight, externalAn ophthalmic device that is applied to the outside of the upper eyelid to "lidload" the eyelid to restore upper eyelid muscle (musculus orbicularis oculi) function. This device can be used for: 1) the treatment of temporary facial paralysis caused by Bell's palsy, trauma, or a stroke; or 2) to determine the appropriate size of implantable eyelid weights prior to surgery. This device uses gravity to gently close the upper eyelid when blinking or when the eyelid muscle is relaxed, and is made of a heavy material (e.g., tantalum). It is worn just above the eyelashes, adhered to the skin with double-sided adhesive tape, and is coloured in a variety of skin shades (pink, tan, brown, dark brown).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
057442048
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813142021303BlinkezeTEW6014-0TEW6014-02023-11-28
00813142021310BlinkezeTEW6014-1TEW6014-12023-11-28
00813142021327BlinkezeTEW6014-2TEW6014-22023-11-28
00813142021334BlinkezeTEW6014-3TEW6014-32023-11-28
00813142021341BlinkezeTEW6014-4TEW6014-42023-11-28
00813142021358BlinkezeTEW6016-0TEW6016-02023-11-28
00813142021365BlinkezeTEW6016-1TEW6016-12023-11-28
00813142021372BlinkezeTEW6016-2TEW6016-22023-11-28
00813142021389BlinkezeTEW6016-3TEW6016-32023-11-28
00813142021396BlinkezeTEW6016-4TEW6016-42023-11-28
00813142021402BlinkezeTEW6018-0TEW6018-02023-11-28
00813142021419BlinkezeTEW6018-1TEW6018-12023-11-28
00813142021426BlinkezeTEW6018-2TEW6018-22023-11-28
00813142021433BlinkezeTEW6018-3TEW6018-32023-11-28
00813142021440BlinkezeTEW6018-4TEW6018-42023-11-28
00813142021457BlinkezeTEW6020-0TEW6020-02023-11-28
00813142021464BlinkezeTEW6020-1TEW6020-12023-11-28
00813142021471BlinkezeTEW6020-2TEW6020-22023-11-28
00813142021488BlinkezeTEW6020-3TEW6020-32023-11-28
00813142021495BlinkezeTEW6020-4TEW6020-42023-11-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
EHKM80001111Test Weight Set Upper Eyelid ImplantHeinz Kurz GmbHMML2026-04-07
00813142021303BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021310BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021327BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021334BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021341BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021358BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021365BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021372BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021389BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021396BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021402BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021419BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021426BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021433BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021440BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021457BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021464BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021471BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021488BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021495BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021501BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021518BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021525BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021532BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021549BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021556BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021563BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021587BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021594BlinkezeMEDDEV CORPORATIONMML2023-11-28