FDA.reportPublic FDA data

I9012

Primary DI
00844369016865
Brand
I9012
Company
Lenstec Barbados Inc
Model
05-2136-B
Device description
Threaded Injector, Course Thread, Large Knob, Titanium
Published
2024-05-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00844369016865PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00844369016865008443690168658443690168650844369016865

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
860235001
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00844369016858I9011S05-21352024-05-06
00844369016872I9012FS05-2138-B2024-05-06
00844369018944LC16LC162024-05-06
00844369018968LC24LC242024-05-06
00844369018975CART45SCART45S2024-05-06
00844369018982CARTMCARTM2024-05-06
00844369038003ClearView 3SBL-3+10.0SBL-32023-01-25
00844369038010ClearView 3SBL-3+10.5SBL-32023-01-25
00844369038027ClearView 3SBL-3+11.0SBL-32023-01-25
00844369038034ClearView 3SBL-3+11.5SBL-32023-01-25
00844369038041ClearView 3SBL-3+12.0SBL-32023-01-25
00844369038058ClearView 3SBL-3+12.5SBL-32023-01-25
00844369038065ClearView 3SBL-3+13.0SBL-32023-01-25
00844369038072ClearView 3SBL-3+13.5SBL-32023-01-25
00844369038089ClearView 3SBL-3+14.0SBL-32023-01-25
00844369038096ClearView 3SBL-3+14.5SBL-32023-01-25
00844369038102ClearView 3SBL-3+15.0SBL-32023-01-25
00844369038119ClearView 3SBL-3+15.25SBL-32023-01-25
00844369038126ClearView 3SBL-3+15.5SBL-32023-01-25
00844369038133ClearView 3SBL-3+15.75SBL-32023-01-25

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
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
00841668142851ASICO ROYALE III INJECTOR W/ LONG SPRINGKATENA PRODUCTS, INC.MSS2022-12-13
00841668142868ASICO ROYALE III INJECTORKATENA PRODUCTS, INC.MSS2022-12-13