FDA.report

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
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
HQNConformer, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HQNConformer, OphthalmicOphthalmic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00854428006348PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00854428006348008544280063488544280063480854428006348

GMDN Terms

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
Ethylene Oxide

Regulatory Flags

DUNS number
118972350
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

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 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
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
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
M8722141204Symblepharon Ring Conformer SmallOculo-Plastik IncHQN2019-10-23
M8722141406Symblepharon Ring Conformer MediumOculo-Plastik IncHQN2019-10-23
10697660002382Symblepharon Ring Conformer LargeOculo-Plastik IncHQN2019-10-23
10697660001095Bilateral Conformer 18/20 SmallOculo-Plastik IncHQN2019-10-21
10697660001118Bilateral Conformer 18/20 RegularOculo-Plastik IncHQN2019-10-21
M8721911208Bilateral Conformer 18 SmallOculo-Plastik IncHQN2019-10-21
10697660001156Bilateral Conformer 18 RegularOculo-Plastik IncHQN2019-10-21
10697660001170Bilateral Conformer 16 SmallOculo-Plastik IncHQN2019-10-21
M872191240Bilateral Conformer 16 RegularOculo-Plastik IncHQN2019-10-21
M872190920Bilateral Conformer 22 SmallOculo-Plastik IncHQN2019-10-18
10697660001026Bilateral Conformer 22 Small With HolesOculo-Plastik IncHQN2019-10-18
M872190940Bilateral Conformer 22 RegularOculo-Plastik IncHQN2019-10-18
M87219094T03Bilateral Conformer 22 Regular With HolesOculo-Plastik IncHQN2019-10-18