FDA.reportPublic FDA data

iPRIME

Primary DI
00853704002456
Brand
iPRIME
Company
GLAUKOS CORPORATION
Model
VCP100
Catalog number
VCP100
Device description
Viscodelivery System
Published
2022-05-13
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
MRHPump, Infusion, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRHPump, Infusion, OphthalmicGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212797000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212797000iPrime Viscodelivery SystemGlaukos2022-01-06MRH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853704002456PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853704002456008537040024568537040024560853704002456

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-useA rigid or semi-rigid tube (non-illuminating) designed to be inserted into the eye to facilitate infusion, irrigation, and/or aspiration of fluids/gases during ophthalmic surgery (e.g., phacoemulsification, vitreoretinal surgery, sub-Tenon’s anaesthesia, capsule polishing). It is a single- or multi-lumen device, typically made of high-grade stainless steel, and may include a length of flexible tubing or a basic handle (without controls). It may be blunt, or include a sharp angled tip/hook (e.g., irrigating cystotome for capsulotomy), however it does not have a sharp bevelled end for initial puncture of the eye (i.e., not a needle). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
949-367-9600Quality@glaukos.com

Regulatory Flags#

DUNS number
012835406
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853704002487iStent inject W Trabecular Micro-Bypass System with Infinite Injector TechnologyiS2iS22025-04-30
00853704002449iStent InfiniteiS3iS3-US2022-10-19
00853704002470iStent infiniteiS3iS32022-10-05
00853704002319iStent inject WG2-WG2-W2020-08-11
00853704002005iStentGTS100RGTS100R2015-09-21
00853704002012iStentGTS100LGTS100L2015-09-21
00853704002029iStentGTS100iGTS100i2015-09-21
00853704002203iStent injectG2-M-ISG2-M-IS2018-07-25
00853704002463iAccessAX1AX12022-05-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00893872001653iTrack 250ENova Eye, Inc.MRH2026-05-05
00858027006594OMNI Edge Surgical SystemSight Sciences, Inc.MRH2025-03-06
00892064002362VIA360 Surgical SystemNEW WORLD MEDICAL, INCORPORATEDMRH2025-02-18
00892064002102Streamline Surgical SystemNEW WORLD MEDICAL, INCORPORATEDMRH2025-02-15
00892064002072Streamline Surgical SystemNEW WORLD MEDICAL, INCORPORATEDMRH2023-11-01
00858027006433OMNI Surgical SystemSight Sciences, Inc.MRH2023-10-17
00844685009381TrabEx ProMICROSURGICAL TECHNOLOGY, INC.MRH2022-09-22
00858027006525OMNI Surgical SystemSight Sciences, Inc.MRH2022-08-22
00892064002010Streamline® Surgical SystemNEW WORLD MEDICAL, INCORPORATEDMRH2021-11-01
00858027006358OMNI PLUSSight Sciences, Inc.MRH2020-10-30
00858027006372OMNI(R) Surgical System (US)Sight Sciences, Inc.MRH2020-06-01
00858027006334OMNI Surgical System (US)Sight Sciences, Inc.MRH2019-10-25
00893872001585ViscoInjectorNova Eye, Inc.MRH2019-01-28
00858027006310OMNI Surgical System (US)Sight Sciences, Inc.MRH2018-03-16
00858027006013VISCO(TM)360 Viscosurgical SystemSight Sciences, Inc.MRH2016-09-22
00893872001059iTrack 250ANova Eye, Inc.MRH2016-09-15
00853480006013Viscous Fluid PackESCALON MEDICAL CORP.MRH2016-01-14
00853480006242Viscous Fluid PackESCALON MEDICAL CORP.MRH2016-01-14
10853480006010Viscous Fluid PackESCALON MEDICAL CORP.MRH2016-01-14
10853480006249Viscous Fluid PackESCALON MEDICAL CORP.MRH2016-01-14