FDA.reportPublic FDA data

Orbital Implant Inserter

Primary DI
05060171621850
Brand
Orbital Implant Inserter
Company
CERAMISYS LTD
Model
INSTR01
Device description
Orbital Implant Inserter
Published
2015-07-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HNPIntroducer, Sphere

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNPIntroducer, SphereOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060171621850PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060171621850050601716218505060171621850

GMDN Terms#

Term, Definition table
TermDefinition
Orbital sphere implant introducerA hand-held manual ophthalmic instrument designed to hold and insert an orbital sphere implant into the orbital cavity (eye socket). It typically has a body made of high-grade stainless steel with a piston used to forward the implant, which is held and positioned by the size-adjustable head of the device. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
423459374
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060171621867Hydroxyapatite Orbital ImplantSP142015-07-31
05060171621874Hydroxyapatite Orbital ImplantSP162015-07-31
05060171621881Hydroxyapatite Orbital ImplantSP182015-07-31
05060171621898Hydroxyapatite Orbital ImplantSP202015-07-31
05060171621904Hydroxyapatite Orbital ImplantSP222015-07-31
05060171621911Alumina Orbital ImplantSA142015-07-31
05060171621928Alumina Orbital ImplantSA162015-07-31
05060171621935Alumina Orbital ImplantSA182015-07-31
05060171621942Alumina Orbital ImplantSA202015-07-31
05060171621959Alumina Orbital ImplantSA222015-07-31
05060171621966Orbtex Orbital ImplantRPX162015-07-31
05060171621973Orbtex Orbital ImplantRPX182015-07-31
05060171621980Orbtex Orbital ImplantRPX202015-07-31
05060171621997Orbtex Orbital ImplantRPX222015-07-31
05060171623281ReproBoneRBD0252015-07-31
05060171623298ReproBoneRBD052015-07-31
05060171623304ReproBoneRBD12015-07-31
05060171623311ReproBoneRBD22015-07-31
05060171623328ReproBoneRBD2.52015-07-31
05060171623335ReproBoneRBD32015-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00194613011734MSI Precision Specialty InstrumentsMed Saver, Inc.HNP2025-03-21
00757770408320Bausch + LombBausch & Lomb IncorporatedHNP2024-11-20
00887482040010Symmetry FoxASPEN SURGICAL PRODUCTS, INC.HNP2024-08-20
00190776360276MillenniumAvalign Technologies, Inc.HNP2023-02-22
14026704802262PILLINGTELEFLEX INCORPORATEDHNP2022-12-08
54026704802260PILLINGTELEFLEX INCORPORATEDHNP2022-12-08
00842331166532Novo Surgical Inc. NOVO SURGICAL, INC.HNP2022-11-13
00190776072155AvalignAvalign Technologies, Inc.HNP2021-11-03
13760087126386SPHERE INTRODUCERFCI S A S FCI 20 22HNP2021-05-30
00190660109325Ambler SurgicalAMBLER SURGICAL CORP.HNP2021-01-07
00841668110836Sphere IntroducerKATENA PRODUCTS, INC.HNP2020-09-14
04046964686665AESCULAPAESCULAP, INC.HNP2020-08-25
03760087126389Orbital sphere implant introducerFCI S A S FCI 20 22HNP2020-02-26
00192896019317CARTER SPHERE INTRODUCERSONTEC INSTRUMENTS, INC.HNP2018-09-14