FDA.reportPublic FDA data

ASICO ROYALE III INJECTOR W/ LONG SPRING

Primary DI
00841668142851
Brand
ASICO ROYALE III INJECTOR W/ LONG SPRING
Company
KATENA PRODUCTS, INC.
Model
AE-9036LSP
Catalog number
AE-9036LSP
Device description
ASICO ROYALE III INJECTOR W/ LONG SPRING
Published
2022-12-13
Public version status
New
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
MSSFolders and injectors, intraocular lens (iol)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MSSFolders And Injectors, Intraocular Lens (Iol)Ophthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841668142851PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841668142851008416681428518416681428510841668142851

GMDN Terms#

Term, Definition table
TermDefinition
Manual intraocular lens injector, reusableA hand-held manual ophthalmic surgical instrument designed to expel (launch) a prepared (folded) intraocular lens (IOL) from an attached IOL insertion cartridge into the anterior or posterior chamber of the eye during ophthalmic implantation surgery. It has a central plunger that is activated by a precise mechanism (e.g., a screw thread) and a mechanism at the distal end to hold/grip the insertion cartridge; it is typically made of lightweight metal materials [e.g., titanium (Ti)]. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
+1(973)989-1600inquiries.corzaeye@corza.com

Regulatory Flags#

DUNS number
085668598
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841668146460BarronK20-2165K20-21652026-06-10
00841668146484BarronK20-2167K20-21672026-06-10
00841668146491BarronK20-2170K20-21702026-06-10
00841668146507BarronK20-2172K20-21722026-06-10
00841668146514BarronK20-2175K20-21752026-06-10
00841668146521BarronK20-2177K20-21772026-06-10
00841668146538BarronK20-2180K20-21802026-06-10
00841668146545BarronK20-2182K20-21822026-06-10
00841668146552BarronK20-2185K20-21852026-06-10
00841668146569BarronK20-2187K20-21872026-06-10
00841668146576BarronK20-2195K20-21952026-06-10
00841668146590BarronK20-2190K20-21902026-06-10
00841668146606BarronK20-2192K20-21922026-06-10
00841668144299KatenaK3-9258K3-92582026-03-31
00841668144305KatenaK3-9259K3-92592026-03-31
00841668144312KatenaK3-9261K3-92612026-03-31
00841668144329KatenaK3-9262K3-92622026-03-31
00841668144336KatenaK3-9263K3-92632026-03-31
00841668144343KatenaK3-9264K3-92642026-03-31
00841668144350KatenaK3-9265K3-92652026-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10757770602497EyeGility™ InserterBausch & Lomb IncorporatedMSS2026-04-05
10757770618115EyeGility™ InserterBausch & Lomb IncorporatedMSS2026-04-05
10814899027454pioli™ IOL Delivery SystemAST PRODUCTS, INC.MSS2026-04-01
07630055212023ACCUJECT 2.2-1P INJECTOR SETMedicel AGMSS2025-12-09
07630055214584ACCUJECT injector Set 2.1-1PMedicel AGMSS2025-09-30
10818806021016RxSight Insertion DeviceRXSIGHT, INC.MSS2024-11-12
00818806021019RxSight Insertion DeviceRXSIGHT, INC.MSS2024-11-12
00844369016858I9011SLenstec Barbados IncMSS2024-05-06
00844369016865I9012Lenstec Barbados IncMSS2024-05-06
00844369016872I9012FSLenstec Barbados IncMSS2024-05-06
00844369018944LC16Lenstec Barbados IncMSS2024-05-06
00844369018968LC24Lenstec Barbados IncMSS2024-05-06
00844369018975CART45SLenstec Barbados IncMSS2024-05-06
00844369018982CARTMLenstec Barbados IncMSS2024-05-06
00757770520183BLIS-X1Bausch & Lomb IncorporatedMSS2024-03-04
00757770523337BLIS-X0Bausch & Lomb IncorporatedMSS2024-03-04
00757770488964Cystalsert Delivery SystemBausch & Lomb IncorporatedMSS2024-01-18
00757770529032Sofport Easy-Load Lens Delivery System EZ-24Bausch & Lomb IncorporatedMSS2024-01-18
07630055214850Accuject REFRA 2.9 InjectorMedicel AGMSS2023-12-08
07630055211934VISCOJECT 2.2 INJECTOR-SETMedicel AGMSS2023-12-01
07630055211941VISCOJECT 1.8 Injector setMedicel AGMSS2023-12-01
20840311300017MicroStaarSTAAR SURGICAL COMPANYMSS2023-06-15
20840311300024MicroStaarSTAAR SURGICAL COMPANYMSS2023-06-15
00840311344796MicroStaarSTAAR SURGICAL COMPANYMSS2023-06-15
00840311344802MicroStaarSTAAR SURGICAL COMPANYMSS2023-06-15
10840311300010MicroStaarSTAAR SURGICAL COMPANYMSS2023-06-15
10840311300027MicroStaarSTAAR SURGICAL COMPANYMSS2023-06-15
00840311300013MicroStaarSTAAR SURGICAL COMPANYMSS2023-06-15
00840311300020MicroStaarSTAAR SURGICAL COMPANYMSS2023-06-15
00841668142868ASICO ROYALE III INJECTORKATENA PRODUCTS, INC.MSS2022-12-13