FDA.reportPublic FDA data

Orbit Subretinal Delivery System

Primary DI
00860000540513
Brand
Orbit Subretinal Delivery System
Company
Gyroscope Usa, Inc.
Model
PN1007128-002C
Device description
Subretinal Access Kit - Curved
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
Single use
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182274000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182274000Orbit Subretinal Delivery SystemOrbit Biomedical, Inc.2018-11-20FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860000540513PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860000540513008600005405138600005405130860000540513

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

Contacts#

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

Regulatory Flags#

DUNS number
071418804
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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
00860000540520Orbit Subretinal Delivery SystemPN10071382019-04-30
00860000540537Orbit Subretinal Delivery SystemPN1007138C2019-04-30
00860000540544Orbit Subretinal Delivery SystemPN10071302019-04-30
00860000540551Orbit Subretinal Delivery SystemPN10072562019-04-30
00860000540568Orbit Subretinal Delivery SystemJANS00302019-04-30

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