FDA.reportPublic FDA data

Janach

Primary DI
05060165019229
Brand
Janach
Company
NETWORK MEDICAL PRODUCTS LIMITED
Model
J4494.1
Device description
J4494.1 - Janach Corneal Light Shield 8mm
Published
2020-08-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HOZSponge, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOZSponge, OphthalmicOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130117000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130117000NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDSNetwork Medical Products, Ltd.2013-10-29HOZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060165019212PrimaryGS10
05060165019229Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060165019212050601650192125060165019212
05060165019229050601650192295060165019229

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic spongeA device made of absorbent material, e.g., gauze, cotton or cellulose, intended to be used to absorb excess fluid produced by the eye during microsurgical procedures and ophthalmic surgery such as cataract surgery and laser assisted in situ keratomileusis (LASIK) procedures. Some types can be used as an eyelid and lash guard and are typically shaped for use in conjunction with an eye speculum. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
458670304
Device count
20
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060165012305Eyetec40-4162019-08-06
05056100707177Eyetec1-4162020-02-25
05060165013166NETCELL37-4162019-08-28
05056100712775Lions World Vision InstituteLWVI-850-6.002025-03-11
05056100712782Lions World Vision InstituteLWVI-850-6.252025-03-11
05056100712805Lions World Vision InstituteLWVI-850-9.502025-03-11
05056100712812Lions World Vision InstituteLWVI-850-6.502025-03-11
05056100712829Lions World Vision InstituteLWVI-850-6.752025-03-11
05056100712836Lions World Vision InstituteLWVI-850-7.002025-03-11
05056100712843Lions World Vision InstituteLWVI-850-7.252025-03-11
05056100712850Lions World Vision InstituteLWVI-850-7.502025-03-11
05056100712867Lions World Vision InstituteLWVI-850-7.752025-03-11
05056100712874Lions World Vision InstituteLWVI-850-8.002025-03-11
05056100712881Lions World Vision InstituteLWVI-850-8.252025-03-11
05056100712904Lions World Vision InstituteLWVI-850-8.752025-03-11
05056100712911Lions World Vision InstituteLWVI-850-9.002025-03-11
05056100712928Lions World Vision InstituteLWVI-850-9.252025-03-11
05056100712935Lions World Vision InstituteLWVI-850-6.002025-03-11
05056100712942Lions World Vision InstituteLWVI-850-6.252025-03-11
05056100712799Lions World Vision InstituteLWVI-850-9.752025-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840516145747Anodyne SurgicalPsi/Eye-Ko, Inc.HOZ2026-04-17
00840516145761Anodyne SurgicalPsi/Eye-Ko, Inc.HOZ2026-04-17
10385640090008WalcottSummit Medical, Inc.HOZ2026-02-03
10385640090015WalcottSummit Medical, Inc.HOZ2026-02-03
30385640090019WalcottSummit Medical, Inc.HOZ2026-02-03
20385640090005WalcottSummit Medical, Inc.HOZ2026-02-03
20385640090012WalcottSummit Medical, Inc.HOZ2026-02-03
40385640090016WalcottSummit Medical, Inc.HOZ2026-02-03
04260306710522Sugi sterile, sample, ophthalmologyQuestAlpha GmbH & Co. KGHOZ2025-08-15
00194613056841MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613056872MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613056896MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613056919MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613056926MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613100070MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613118778MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613118785MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613118792MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613118808MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613118983MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613118990MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613119003MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613119010MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613119027MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-08-01
00194613056889MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2025-03-21
00194613018276MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2024-08-15
00194613060749MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2024-08-15
10194613018273MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2024-08-15
10194613060746MSI Precision Specialty InstrumentsMed Saver, Inc.HOZ2024-08-15
04260306710478SugiQuestAlpha GmbH & Co. KGHOZ2024-07-31