FDA.reportPublic FDA data

Lucite Conformer

Primary DI
00854428006218
Brand
Lucite Conformer
Company
Jardon Eye Prosthetics, Inc.
Model
Large
Published
2023-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
HQNConformer, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQNConformer, OphthalmicOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854428006218PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854428006218008544280062188544280062180854428006218

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic conformerAn ophthalmic device, typically constructed from moulded plastic, that is intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity and prevent closure or adhesions during the healing process following eye surgery. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
118972350
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854428006003Surgical Eye ShieldPediatric Orange2023-06-26
00854428006010Surgical Eye ShieldPediatric Green2023-06-26
00854428006027Surgical Eye ShieldPediatric White2023-06-26
00854428006034Surgical Eye ShieldPediatric Clear2023-06-26
00854428006041Surgical Eye ShieldSmall Orange2023-06-26
00854428006058Surgical Eye ShieldSmall Green2023-06-26
00854428006065Surgical Eye ShieldSmall Clear2023-06-26
00854428006072Surgical Eye ShieldSmall Black2023-06-26
00854428006089Surgical Eye ShieldSmall White2023-06-26
00854428006096Surgical Eye ShieldMedium Orange2023-06-26
00854428006102Surgical Eye ShieldMedium Green2023-06-26
00854428006119Surgical Eye ShieldMedium Clear2023-06-26
00854428006126Surgical Eye ShieldMedium White2023-06-26
00854428006133Surgical Eye ShieldMedium Black2023-06-26
00854428006140Surgical Eye ShieldLarge Orange2023-06-26
00854428006157Surgical Eye ShieldLarge Green2023-06-26
00854428006164Surgical Eye ShieldLarge Clear2023-06-26
00854428006188Surgical Eye ShieldLarge White2023-06-26
00854428006195Lucite ConformerSmall2023-06-26
00854428006201Lucite ConformerMedium2023-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
CONFV2628Soper Brothers CustomSoper Brothers, IncorporatedHQN2026-03-03
00860015162823Dallas Eye ProstheticsDallas Eye ProstheticsHQN2025-12-23
G568V2628Ophthalmic ConformerTHOMPSON OCULAR PROSTHETICS, INC.HQN2025-03-10
B796V2628Ophthalmic ConformerMIDWEST EYE LABORATORIES, INC.HQN2024-03-28
G519V2628Ophthalmic ConformerMidwest Eye Laboratories Sioux Falls, LLCHQN2024-03-10
G290V2628Ophthalmic ConformerMidwest Eye Laboratories Woodbury, LLCHQN2024-02-20
G542V26280Ophthalmic ConformerTHE EYE CONCERN, INC.HQN2024-01-10
G521V2628Ophthalmic ConformerLegrand AssociatesHQN2023-10-18
00854428006195Lucite ConformerJardon Eye Prosthetics, Inc.HQN2023-06-26
00854428006201Lucite ConformerJardon Eye Prosthetics, Inc.HQN2023-06-26
00854428006348Silicone ConformerJardon Eye Prosthetics, Inc.HQN2023-06-26
00854428006355Silicone ConformerJardon Eye Prosthetics, Inc.HQN2023-06-26
00854428006362Silicone ConformerJardon Eye Prosthetics, Inc.HQN2023-06-26
10697660001002Bilateral Conformers 22 Extra-SmallOculo-Plastik IncHQN2021-06-08
13700773724908SYMBLEPHARON RING 25 MMFCI S A S FCI 20 22HQN2021-05-30
13700773724915SYMBLEPHARON RING 20 MMFCI S A S FCI 20 22HQN2021-05-30
13700773724922SYMBLEPHARON RING 22 MMFCI S A S FCI 20 22HQN2021-05-30
03760087122589SILICONE CONFORMER (FLEXIBLE)FCI S A S FCI 20 22HQN2021-05-30
B863E661090V2628Ophthalmic ConformerTEXAS EYE PROSTHETICS LLCHQN2020-04-14
03760087122732Ophthalmic conformerFCI S A S FCI 20 22HQN2020-03-06
03760087122749Ophthalmic conformerFCI S A S FCI 20 22HQN2020-03-06
03760087122756Ophthalmic conformerFCI S A S FCI 20 22HQN2020-03-06
10697660002344Symblepharon Ring Conformer SmallOculo-Plastik IncHQN2019-10-23
10697660002368Symblepharon Ring Conformer MediumOculo-Plastik IncHQN2019-10-23
10697660002382Symblepharon Ring Conformer LargeOculo-Plastik IncHQN2019-10-23
10697660001132Bilateral Conformer 18 SmallOculo-Plastik IncHQN2019-10-21
10697660001194Bilateral Conformer 16 RegularOculo-Plastik IncHQN2019-10-21
10697660001095Bilateral Conformer 18/20 SmallOculo-Plastik IncHQN2019-10-21
10697660001118Bilateral Conformer 18/20 RegularOculo-Plastik IncHQN2019-10-21
10697660001156Bilateral Conformer 18 RegularOculo-Plastik IncHQN2019-10-21