FDA.reportPublic FDA data

Orbit Subretinal Delivery System

Primary DI
00860000540568
Brand
Orbit Subretinal Delivery System
Company
Gyroscope Usa, Inc.
Model
JANS0030
Device description
Third Arm Kit
Published
2019-04-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston
HMXCannula, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2
HMXCannula, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860000540568PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860000540568008600005405688600005405680860000540568

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgical procedure kit, non-medicated, single-useA collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
267-523-2100quality@orbitbiomedical.com

Regulatory Flags#

DUNS number
071418804
Device count
1
DM exempt
true
Kit
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
00850009362001Orbit Subretinal Delivery SystemPN1008904-0012020-09-29
00850009362018Orbit Subretinal Delivery SystemPN1008919-0012020-09-29
00850009362025Orbit Subretinal Delivery SystemPN1008927-0012020-09-29
00850009362032Orbit Subretinal Delivery SystemPN1008946-0012020-09-29
00860000540506Orbit Subretinal Delivery SystemPN1007128-0022019-04-30
00860000540513Orbit Subretinal Delivery SystemPN1007128-002C2019-04-30
00860000540520Orbit Subretinal Delivery SystemPN10071382019-04-30
00860000540537Orbit Subretinal Delivery SystemPN1007138C2019-04-30
00860000540544Orbit Subretinal Delivery SystemPN10071302019-04-30
00860000540551Orbit Subretinal Delivery SystemPN10072562019-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05391530754255polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754279polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754286polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754323polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754385polycarbonate syringesDMC MEDICAL LIMITEDFMF2026-09-27
05391530754415polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754477polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754484polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754651polycarbonate syringesDMC MEDICAL LIMITEDFMF2026-09-27
05391530754736polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
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00850091070426CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070433CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00190776428228MillenniumAvalign Technologies, Inc.HMX2026-08-27
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