FDA.reportPublic FDA data

EZYPOR® Ø 18 mm

Primary DI
13700773724397
Brand
EZYPOR® Ø 18 mm
Company
FCI S A S FCI 20 22
Model
S6.6018
Device description
Orbital implant
Published
2024-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HPZImplant, Eye Sphere

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HPZImplant, Eye SphereOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
13700773724397PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1370077372439713700773724397

GMDN Terms#

Term, Definition table
TermDefinition
Orbital sphere implantAn implantable ocular device designed to permanently fill the orbital cavity following enucleation, evisceration, or after the removal of another ocular implant (used as a secondary implant), to replace the volume and possibly, given the surgical method, to impart motion to the eventual ocular prosthesis (the artificial eyeball). It is typically aspherical and may have porous surfaces to facilitate colonization by fibrovascular tissue to offer the advantages of reduced risk of infection or implant extrusion. It is available in various sizes and is typically made of polymethylmethacrylate (PMMA), poly 2-hydroxyethylmethacrylate (PHEMA), or silicone.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
763408366
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
13700773729651STOPLOSS® JONES TUBE 3,5 X 9 MM S1.73092026-04-20
13700773729668STOPLOSS® JONES TUBE 3,5 X 10 MM S1.73102026-04-20
13700773729675STOPLOSS® JONES TUBE 3,5 X 11 MM S1.73112026-04-20
13700773729682STOPLOSS® JONES TUBE 3,5 X 12 MM S1.73122026-04-20
13700773729699STOPLOSS® JONES TUBE 3,5 X 13 MM S1.73132026-04-20
13700773730817STOPLOSS® JONES TUBE INTRODUCER SET S1.75002026-04-20
13700773731920STOPLOSS® JONES TUBE 3,5 X 14 MM S1.73142026-04-20
13700773731937STOPLOSS® JONES TUBE 3,5 X 15 MM S1.73152026-04-20
13700773731968STOPLOSS® JONES TUBE 3,5 X 16 MM S1.73162026-04-20
13700773731975STOPLOSS® JONES TUBE 3,5 X 17 MM S1.73172026-04-20
13700773731982STOPLOSS® JONES TUBE 3,5 X 18 MM S1.73182026-04-20
13700773731999STOPLOSS® JONES TUBE 3,5 X 19 MM S1.73192026-04-20
13700773732002STOPLOSS® JONES TUBE 3,5 X 20 MM S1.73202026-04-20
13700773732019STOPLOSS® JONES TUBE 3,5 X 21 MM S1.73212026-04-20
13700773732026STOPLOSS® JONES TUBE 3,5 X 22 MM S1.73222026-04-20
13700773732033STOPLOSS® JONES TUBE 4 X 9 MM S1.74092026-04-20
13700773732040STOPLOSS® JONES TUBE 4 X 10 MM S1.74102026-04-20
13700773732057STOPLOSS® JONES TUBE 4 X 11 MM S1.74112026-04-20
13700773732064STOPLOSS® JONES TUBE 4 X 12 MM S1.74122026-04-20
13700773732071STOPLOSS® JONES TUBE 4 X 13 MM S1.74132026-04-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
13700773728111SIZERS SET (ENUCLEATION / EVISCERATION) SINGLE USEFCI S A S FCI 20 22HPZ2026-02-17
13700773724403EZYPOR® Ø 20 mm FCI S A S FCI 20 22HPZ2024-06-21
13700773724410EZYPOR® Ø 22 mm FCI S A S FCI 20 22HPZ2024-06-21
13700773728081EZYPOR® Ø 16 mm FCI S A S FCI 20 22HPZ2024-06-21
13700773728852EZYPOR® Ø 12 mm FCI S A S FCI 20 22HPZ2024-06-21
13700773728890EZYPOR® Ø 14 mm FCI S A S FCI 20 22HPZ2024-06-21
B09114150010mm Eye Sphere (non-sterile)Gulden Ophthalmics Inc.HPZ2023-07-19
B09114151012mm Eye Sphere (non-sterile)Gulden Ophthalmics Inc.HPZ2023-07-19
B09114152014mm Eye Sphere (non-sterile)Gulden Ophthalmics Inc.HPZ2023-07-19
B09114153016mm Eye Sphere (non-sterile)Gulden Ophthalmics Inc.HPZ2023-07-19
B09114154018mm Eye Sphere (non-sterile)Gulden Ophthalmics Inc.HPZ2023-07-19
B09114155020mm Eye Sphere (non-sterile)Gulden Ophthalmics Inc.HPZ2023-07-19
B09114156022mm Eye Sphere (non-sterile)Gulden Ophthalmics Inc.HPZ2023-07-19
03760087123715SIZERS SET (ENUCLEATION / EVISCERATION) SINGLE USEFCI S A S FCI 20 22HPZ2021-05-30
13760087123712SIZERS SET (ENUCLEATION / EVISCERATION) SINGLE USEFCI S A S FCI 20 22HPZ2021-05-30
03760087122435Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122442Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122459Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122466Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122473Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122480Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122510Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122527Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122916Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122923Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122930Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122954Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122961Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122985Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087123067Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06