FDA.reportPublic FDA data

Silicone Conformer

Primary DI
00854428006348
Brand
Silicone Conformer
Company
Jardon Eye Prosthetics, Inc.
Model
Small
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
00854428006348PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854428006348008544280063488544280063480854428006348

GMDN Terms#

Term, Definition table
TermDefinition
Surgical eye pressure shieldA non-sterile device intended to cover and mechanically protect the eyes of a patient during surgery to prevent potential ocular pressure hazards/injury associated with surgery (e.g., resulting from inadvertent pressure being applied to the eye by healthcare professionals, equipment, or due to the orientation of the patient). It is designed as a rigid external eye shield (e.g., goggle like) intended to adhere to the face. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
118972350
Device count
1
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
00854428006218Lucite 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