FDA.reportPublic FDA data

Bio-Eye®

Primary DI
00854066006106
Brand
Bio-Eye®
Company
INTEGRATED ORBITAL IMPLANTS INC
Model
I0020P
Device description
Perforated Coated Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and eviscerations.
Published
2015-12-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HPZImplant, Eye Sphere
HQNConformer, Ophthalmic
MTZWrap, Implant, Orbital

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HPZImplant, Eye SphereOphthalmic2
HQNConformer, OphthalmicOphthalmic2
MTZWrap, Implant, OrbitalOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K003338000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K003338000BIO-EYE II ORBITAL IMPLANTIntegrated Orbital Implants, Inc.2001-02-07HPZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854066006106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854066006106008540660061068540660061060854066006106

GMDN Terms#

Term, Definition table
TermDefinition
Orbital sphere implant wrap, non-biologicalA sterile implantable ocular device used as an external cover (a wrap) for an orbital implant used in enucleation surgery, and to protect the surrounding orbital tissue from the surface of the implant. It is typically made of resorbable materials available in sheet form [e.g., polylactide (PLA)] that can be cut to the desired shape and size. It may be made malleable by submersion in hot water, after which it can be formed to any three-dimensional (3-D) anatomical orientation. It will typically contain pores that allow for natural tissue ingrowth.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter20Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-424-6537haimplants@ioi.com

Regulatory Flags#

DUNS number
859186348
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854066006236P-K Titanium Motility Peg SystemI000572024-03-15
00854066006052Bio-Eye®I0018C2015-12-01
00854066006069Bio-Eye®I0020C2015-12-01
00854066006076Bio-Eye®I0022C2015-12-01
00854066006083Bio-Eye®I0016P2015-12-01
00854066006090Bio-Eye®I0018P2015-12-01
00854066006113Bio-Eye®I0022P2015-12-01
00854066006120Bio-Eye®I0024P2015-12-01
00854066006007Bio-Eye®I00016S2015-12-01
00854066006014Bio-Eye®I00018S2015-12-01
00854066006021Bio-Eye®I00020S2015-12-01
00854066006038Bio-Eye®I00022S2015-12-01
00854066006045Bio-Eye®I00024S2015-12-01
00854066006168P-K Titanium Motility Peg SystemI000452015-12-01
00854066006175P-K Titanium Motility Peg SystemI001002015-12-01
00854066006182P-K Titanium Motility Peg SystemI000492015-12-01
00854066006199P-K Titanium Motility Peg SystemI000512015-12-01
00854066006205P-K Titanium Motility Peg SystemI000872015-12-01
00854066006212P-K Titanium Motility Peg SystemI000892015-12-01
00854066006137NAI000412015-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
CONFV2628Soper Brothers CustomSoper Brothers, IncorporatedHQN2026-03-03
13700773728111SIZERS SET (ENUCLEATION / EVISCERATION) SINGLE USEFCI S A S FCI 20 22HPZ2026-02-17
00860015162823Dallas Eye ProstheticsDallas Eye ProstheticsHQN2025-12-23
G568V2628Ophthalmic ConformerTHOMPSON OCULAR PROSTHETICS, INC.HQN2025-03-10
13700773724397EZYPOR® Ø 18 mm FCI S A S FCI 20 22HPZ2024-06-21
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
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
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
00854428006195Lucite ConformerJardon Eye Prosthetics, Inc.HQN2023-06-26
00854428006201Lucite ConformerJardon Eye Prosthetics, Inc.HQN2023-06-26
00854428006218Lucite 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