FDA.reportPublic FDA data

NAVIJECT SUB2-1P INJECTOR SET

Primary DI
07630055222107
Brand
NAVIJECT SUB2-1P INJECTOR SET
Company
Medicel AG
Model
LP604430W
Catalog number
LP604430W
Device description
Injectors and cartridges for the injection of intraocular lenses (IOL) into the eye during surgical procedures.
Published
2020-10-21
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
MSSFolders And Injectors, Intraocular Lens (Iol)

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092023000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092023000NAVIJECT SUB2-1P, MODEL: LP604430Medicel AG2009-07-28MSS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630055222107PrimaryGS10
07630055213976Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630055222107076300552221077630055222107
07630055213976076300552139767630055213976

GMDN Terms#

Term, Definition table
TermDefinition
Manual intraocular lens injector, single-useA 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 plastic materials. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+41717271050info@medicel.com

Regulatory Flags#

DUNS number
487158263
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630055214935VISCOJECT 1.8 Injector SetLP604350LP6043502026-04-28
07630055213853VISCOJECT 2.2 Injector SetLP604340LP6043402026-04-24
07630055212023ACCUJECT 2.2-1P INJECTOR SETLP604530LP6045302025-12-09
07630055244055BICEL SOFT TIP I/A curved / 21G terralutionBIT21ASBIT21AS2025-12-09
07630055214584ACCUJECT injector Set 2.1-1PLP604590LP6045902025-09-30
07630055244031BICEL I/A curved / 21G terralutionBIT21A2025-05-28
07630055244048BICEL I/A curved / 23G terralutionBIT23A2025-05-28
07630055241863I/A Coaxial Handpiece Set Sophi - 20G/65°1401-22301401-22302024-11-28
07630055241870I/A Coaxial Handpiece Set Sophi - 21G/45°1401-22211401-22212024-11-28
07630055241887I/A Coaxial Handpiece Set Sophi - 23G/45°1401-22231401-22232024-11-28
07630055241894I/A Coaxial Handpiece Set Sophi - 21G/45° Soft-Tip1401-22431401-22432024-11-28
07630055243287I/A Bimanual Handpiece Set Sophi -21G/Aeroplane1401-21301401-21302024-11-28
07630055243959I/A Coaxial Handpiece Set Sophi - 20G/45°1401-22202024-11-28
07630055240835Phaco Accessory SetPA603901PA6039012023-12-01
07630055240859Phaco Accessory SetPA603903PA6039032023-12-01
07630055240866Phaco Accessory SetPA603904PA6039042023-12-01
07630055243744Phaco Accessory SetPA603951PA6039512023-12-01
07630055243751Phaco Accessory SetPA603952PA6039522023-12-01
07630055243768Phaco Accessory SetPA603953PA6039532023-12-01
07630055214850Accuject REFRA 2.9 InjectorREV.PAR29002023-12-08

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