FDA.reportPublic FDA data

SUPER VIEW® Disposable Wide Field Lens for ZEISS RESIGHT®

Primary DI
10856222004657
Brand
SUPER VIEW® Disposable Wide Field Lens for ZEISS RESIGHT®
Company
INSIGHT INSTRUMENTS, INC.
Model
TS-ZR-SV
Catalog number
40424
Device description
1 Each Sterile Disposable Wide Field Lens for use with the ZEISS RESIGHT®. Distributed by THEA Surgical (Insight's REF 40424)
Published
2016-09-23
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
HJLLens, Condensing, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJLLens, Condensing, DiagnosticOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10856222004657PackageGS120In Commercial Distribution
00856222004650PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085622200465710856222004657
00856222004650008562220046508562220046500856222004650

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic condensing lensAn ophthalmic lens used in binocular indirect ophthalmoscopy (a procedure that produces an inverted or reversed direct magnified image of the eye) to focus reflected light from the fundus of the eye. Compared to direct ophthalmosocoy, the indirect method enables better viewing of the peripheral region of the fundus out to the ora serrata (serrated junction between the retina and the ciliary body).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter18Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(772) 219-9393CustomerService@InsightInstruments.com

Regulatory Flags#

DUNS number
828348391
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856222004834SUPER VIEW® Pack for ZEISS RESIGHT®TS-RP-7001402242016-09-23
00856222004841SUPER VIEW® Pack for ZEISS RESIGHT®TS-RP-7002402252016-09-23
00856222004049SUPER VIEW® Disposable Lens Set for RESIGHT®40219402192016-09-23
00856222004063SUPER VIEW® Disposable Lens Set for ZEISS RESIGHT®TS-ZR-LS402262016-09-23
00856222004650SUPER VIEW® Disposable Wide Field Lens for ZEISS RESIGHT®TS-ZR-SV404242016-09-23
00856222004827SUPER VIEW® Disposable Wide Field Lens Set for RESIGHT®40414404142016-09-23
10856222004831SUPER VIEW® Pack for ZEISS RESIGHT®TS-RP-7001402242016-09-23
10856222004848SUPER VIEW® Pack for ZEISS RESIGHT®TS-RP-7002402252016-09-23
00856222004629Insight Instruments, Inc. Infusion Cannula60013600132016-09-23
10856222004626Insight Instruments, Inc. Infusion Cannula60013600132016-09-23
10856222004046SUPER VIEW® Disposable Lens Set for RESIGHT®40219402192016-09-23
10856222004060SUPER VIEW® Disposable Lens Set for ZEISS RESIGHT®TS-ZR-LS402262016-09-23
00856222004636INTRECTOR®71004710042016-09-23
00856222004674RETRECTOR®71005710052016-09-23
00852475007004Insight Instruments, Inc. Vitreous Biopsy Probe 27 Ga71007.1002016-09-23
00852475007011Insight Instruments, Inc. Vitreous Biopsy Probe 27 Ga71007710072016-09-23
00856222004186INTRECTOR®71102711022016-09-23
00856222004193INTRECTOR®71101711012016-09-23
10856222004633INTRECTOR®71004710042016-09-23
00856222004643INTRECTOR®71004.1002016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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0081160801982628D Limited Edition #2VOLK OPTICAL INC.HJL2025-08-01
00811608019833Pan Retinal 2.2 Limited Edition #2VOLK OPTICAL INC.HJL2025-08-01
0081160801984078D Limited Edition #2VOLK OPTICAL INC.HJL2025-08-01
0081160801985790D Limited Edition #2VOLK OPTICAL INC.HJL2025-08-01
00811608019864Super 66® Limited Edition #2VOLK OPTICAL INC.HJL2025-08-01
00811608019871SuperField® Limited Edition #2VOLK OPTICAL INC.HJL2025-08-01
00811608019888Digital Wide Field® Limited Edition #2VOLK OPTICAL INC.HJL2025-08-01
0081160801476020D Limited EditionVOLK OPTICAL INC.HJL2024-09-26
0081160801477728D Limited EditionVOLK OPTICAL INC.HJL2024-09-26
00811608014784Pan Retinal 2.2 Limited EditionVOLK OPTICAL INC.HJL2024-09-26
00811608014791Digital ClearField Limited EditionVOLK OPTICAL INC.HJL2024-09-26
0081160801480778D Limited EditionVOLK OPTICAL INC.HJL2024-09-26
0081160801481490D Limited EditionVOLK OPTICAL INC.HJL2024-09-26
00811608014821Super 66® Limited EditionVOLK OPTICAL INC.HJL2024-09-26
00811608014838SuperField® Limited EditionVOLK OPTICAL INC.HJL2024-09-26
00811608014845Digital Wide Field® Limited EditionVOLK OPTICAL INC.HJL2024-09-26
00811608014852Digital High Mag® Limited EditionVOLK OPTICAL INC.HJL2024-09-26
00841668144268Primary Lens Set, 28D, 90D, 3 MirrorKATENA PRODUCTS, INC.HJL2024-04-11
00841668144275Primary Lens Set, 28D, 90D, 4 MirrorKATENA PRODUCTS, INC.HJL2024-04-11
00850054345004eZView 125Ion Vision, IncHJL2023-08-23
00850054345011eZView 20DIon Vision, IncHJL2023-08-23
00850054345028SurgiView 20DIon Vision, IncHJL2023-08-23
00850054345035eZView 90DIon Vision, IncHJL2023-08-23
00850054345042eZView 78DIon Vision, IncHJL2023-08-23
00850054345059eZView 60DIon Vision, IncHJL2023-08-23
00850054345066eZView 15DIon Vision, IncHJL2023-08-23
00850054345073eZView 25DIon Vision, IncHJL2023-08-23
00850054345080eZView 28DIon Vision, IncHJL2023-08-23
00850054345097SurgiView 28DIon Vision, IncHJL2023-08-23