FDA.reportPublic FDA data

SURGICAL WIDE FIELD LENS WITH HANDLE

Primary DI
10841668111786
Brand
SURGICAL WIDE FIELD LENS WITH HANDLE
Company
KATENA PRODUCTS, INC.
Model
K30-1520
Catalog number
K30-1520
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HJKLens, Contact, Polymethylmethacrylate, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJKLens, Contact, Polymethylmethacrylate, DiagnosticOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841668111786PackageGS110In Commercial Distribution
20841668111783PackageGS110In Commercial Distribution
00841668111789PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084166811178610841668111786
2084166811178320841668111783
00841668111789008416681117898416681117890841668111789

GMDN Terms#

Term, Definition table
TermDefinition
Vitrectomy contact lens, single-useA sterile ophthalmic lens intended to be placed on the cornea of a patient to improve visualization of the fundus and retinal structures by surgical staff using an ophthalmic microscope during vitreoretinal surgery. Also known as a vitrectomy sutureless lens (VSL), it is made of various transparent materials [e.g., polymethylmethacrylate (PMMA), glass, quartz]. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(973) 989-1600globe@katena.com

Regulatory Flags#

DUNS number
085668598
Device count
1
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
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
00841668144367KatenaK3-9266K3-92662026-03-31
00841668144374KatenaK3-9267K3-92672026-03-31
00841668144381KatenaK5-6220K5-62202026-03-31
00841668144398KatenaK3-9268K3-92682026-03-31
00841668144404KatenaK3-9269K3-92692026-03-31
00841668144428KatenaK3-9270K3-92702026-03-31
00841668144435KatenaK3-9274K3-92742026-03-31
00841668144442KatenaK3-9271K3-92712026-03-31
00841668144497BLINK60-127560-12752026-03-26
00841668144619BLINK60-163760-16372026-03-26
00841668144626BLINK60-163860-16382026-03-26
00841668144657BLINK60-500160-50012026-03-26
00841668144855BLINK60-510860-51082026-03-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841668123942KATENAKATENA PRODUCTS, INC.HJK2026-03-02
00841668144466KATENAKATENA PRODUCTS, INC.HJK2026-03-02
00841668144473KATENAKATENA PRODUCTS, INC.HJK2026-03-02
10841668123949KATENAKATENA PRODUCTS, INC.HJK2026-03-02
10841668144463KATENAKATENA PRODUCTS, INC.HJK2026-03-02
10841668144470KATENAKATENA PRODUCTS, INC.HJK2026-03-02
00818806021774RxSight Contact LensRXSIGHT, INC.HJK2025-09-05
00811608014869Capsulotomy (VLUCAPS)VOLK OPTICAL INC.HJK2025-01-29
00811608015934Iridectomy (VLUIRID)VOLK OPTICAL INC.HJK2025-01-29
00856222004209SUPER VIEW Lens, Disposable Contact, TornambeOCULUS SURGICAL INCHJK2024-08-13
10856222004206SUPER VIEW Lens, Disposable Contact, TornambeOCULUS SURGICAL INCHJK2024-08-13
00811608014654Single Use Indirect Wide Field (VVITSSVDH)VOLK OPTICAL INC.HJK2023-10-19
10811608014675Single Use Indirect Wide Field (VVITSSVDH)VOLK OPTICAL INC.HJK2023-10-19
03760087122343SINGLE USE 3 MIRRORS CONTACT LENSFCI S A S FCI 20 22HJK2021-05-30
00852475007202"Contact Lens, HD Professional, Cohen-Benner, ""CBC"""OCULUS SURGICAL INCHJK2021-02-26
10852475007209Contact Lens, HD Professional, Cohen-Benner, "CBC"OCULUS SURGICAL INCHJK2021-02-26
00852475007042SUPER VIEW® Lens Set, HD Plus, Disposable for ZEISS RESIGHT®OCULUS SURGICAL INCHJK2020-11-24
00852475007059SUPER VIEW® Lens Set, HD Plus, Disposable for ZEISS RESIGHT®OCULUS SURGICAL INCHJK2020-11-24
00818806020531RxSight Contact LensRXSIGHT, INC.HJK2020-10-16
03760087122176Ophthalmic surgical procedure kit, non-medicated, single-useFCI S A S FCI 20 22HJK2020-03-06
03760087122190Ophthalmic surgical procedure kit, non-medicated, single-useFCI S A S FCI 20 22HJK2020-03-06
03760087122206Vitrectomy contact lens, single-useFCI S A S FCI 20 22HJK2020-03-06
03760087122213Vitrectomy contact lens, single-useFCI S A S FCI 20 22HJK2020-03-06
03760087123685Vitrectomy contact lens, single-useFCI S A S FCI 20 22HJK2020-03-06
03760087123692Vitrectomy contact lens, single-useFCI S A S FCI 20 22HJK2020-03-06
03760087123708Vitrectomy contact lens, single-useFCI S A S FCI 20 22HJK2020-03-06
53760087122171Ophthalmic surgical procedure kit, non-medicated, single-useFCI S A S FCI 20 22HJK2020-03-06
53760087122195Ophthalmic surgical procedure kit, non-medicated, single-useFCI S A S FCI 20 22HJK2020-03-06
53760087122201Vitrectomy contact lens, single-useFCI S A S FCI 20 22HJK2020-03-06
53760087122218Vitrectomy contact lens, single-useFCI S A S FCI 20 22HJK2020-03-06