FDA.reportPublic FDA data

JEDMED

Primary DI
M6332815660
Brand
JEDMED
Company
JEDMED INSTRUMENT COMPANY
Model
28-1566
Catalog number
28-1566
Device description
TEST WEIGHT F/LID-CHAIN 1.6GM
Published
2023-02-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NCBWeights, Eyelid, Implantable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NCBWeights, Eyelid, ImplantableOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M6332815660PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Eyelid weight, implantableAn ophthalmic device that is implanted subcutaneously within the upper eyelid to "lidload" the eyelid to restore upper eyelid muscle (musculus orbicularis oculi) function. This device is used for the treatment of lagophthalmos, a condition that frequently results from facial paralysis caused by Bell's palsy, trauma, a stroke, or as an indirect consequence of the surgical removal of certain types of tumour in close proximity to the facial nerve. 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., gold (Au), platinum (Pt)].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
092987189
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M6339982060JEDMED99-820699-82062023-02-03
M6339977070JEDMED99-770799-77072023-02-03
M6339977080JEDMED99-770899-77082023-02-03
M6339977090JEDMED99-770999-77092023-02-03
M6339977100JEDMED99-771099-77102023-02-03
M6339977110JEDMED99-771199-77112023-02-03
M6339977120JEDMED99-771299-77122023-02-03
M6339977400JEDMED99-774099-77402023-02-03
M6339977410JEDMED99-774199-77412023-02-03
M6339977420JEDMED99-774299-77422023-02-03
M6339977430JEDMED99-774399-77432023-02-03
M6339977450JEDMED99-774599-77452023-02-03
M6339977460JEDMED99-774699-77462023-02-03
M63399774610JEDMED99-7746-199-7746-12023-02-03
M6339977470JEDMED99-774799-77472023-02-03
M6339977480JEDMED99-774899-77482023-02-03
M6339977490JEDMED99-774999-77492023-02-03
M6339977500JEDMED99-775099-77502023-02-03
M6339978000JEDMED99-780099-78002023-02-03
M6339978100JEDMED99-781099-78102023-02-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M6332815560JEDMEDJEDMED INSTRUMENT COMPANYNCB2023-02-03
M6332815580JEDMEDJEDMED INSTRUMENT COMPANYNCB2023-02-03
M6332815600JEDMEDJEDMED INSTRUMENT COMPANYNCB2023-02-03
M6332815620JEDMEDJEDMED INSTRUMENT COMPANYNCB2023-02-03
M6332815640JEDMEDJEDMED INSTRUMENT COMPANYNCB2023-02-03
M6332815680JEDMEDJEDMED INSTRUMENT COMPANYNCB2023-02-03
M6332815700JEDMEDJEDMED INSTRUMENT COMPANYNCB2023-02-03
13700773724519OCULID GOLD 0.6gFCI S A S FCI 20 22NCB2022-03-08
13700773724526OCULID GOLD 0.8gFCI S A S FCI 20 22NCB2022-03-08
13700773724533OCULID GOLD 1,0gFCI S A S FCI 20 22NCB2022-03-08
13700773724540OCULID GOLD 1,2gFCI S A S FCI 20 22NCB2022-03-08
13700773724557OCULID GOLD 1,4gFCI S A S FCI 20 22NCB2022-03-08
13700773724564OCULID GOLD 1,6gFCI S A S FCI 20 22NCB2022-03-08
13700773724571OCULID GOLD 1.8gFCI S A S FCI 20 22NCB2022-03-08
13700773724588OCULID GOLD SLIM 0,6gFCI S A S FCI 20 22NCB2022-03-08
13700773724595OCULID GOLD SLIM 0,8gFCI S A S FCI 20 22NCB2022-03-08
13700773724601OCULID GOLD SLIM 1,0gFCI S A S FCI 20 22NCB2022-03-08
13700773724618OCULID GOLD SLIM 1,2gFCI S A S FCI 20 22NCB2022-03-08
13700773724625OCULID GOLD SLIM 1,4gFCI S A S FCI 20 22NCB2022-03-08
13700773724632OCULID GOLD SLIM 1,6 gFCI S A S FCI 20 22NCB2022-03-08
13700773724649OCULID PLATINUM SLIM® 0,6 gFCI S A S FCI 20 22NCB2022-03-08
13700773724656OCULID PLATINUM SLIM® 0,8 gFCI S A S FCI 20 22NCB2022-03-08
13700773724663OCULID PLATINUM SLIM® 1,0 gFCI S A S FCI 20 22NCB2022-03-08
13700773724670OCULID PLATINUM SLIM® 1,2 gFCI S A S FCI 20 22NCB2022-03-08
13700773724687OCULID PLATINUM SLIM® 1,4 gFCI S A S FCI 20 22NCB2022-03-08
13700773724694OCULID PLATINUM SLIM® 1,6 gFCI S A S FCI 20 22NCB2022-03-08
13700773724939OCULID GOLD 2,0gFCI S A S FCI 20 22NCB2022-03-08
13700773724946OCULID GOLD 2,2gFCI S A S FCI 20 22NCB2022-03-08
13700773724953OCULID GOLD 2,4gFCI S A S FCI 20 22NCB2022-03-08
13700773724960OCULID GOLD 2,6gFCI S A S FCI 20 22NCB2022-03-08