FDA.reportPublic FDA data

SurgiView 20D

Primary DI
00850054345028
Brand
SurgiView 20D
Company
Ion Vision, Inc
Model
P-IOV-002-SS
Published
2023-08-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00850054345028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850054345028008500543450288500543450280850054345028

GMDN Terms#

Term, Definition table
TermDefinition
Surgical camera lensAn optical element of a surgical camera designed to change the degree of convergence or divergence of transmitted light to enable modification of viewed images (e.g., magnification, wide angle). It is made of glass and is available in a variety of dimensions. This is a non-sterilizable, reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
010759642
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850054345004eZView 125P-IOV-0012023-08-23
00850054345011eZView 20DP-IOV-0022023-08-23
00850054345035eZView 90DP-IOV-0032023-08-23
00850054345042eZView 78DP-IOV-0042023-08-23
00850054345059eZView 60DP-IOV-0052023-08-23
00850054345066eZView 15DP-IOV-0062023-08-23
00850054345073eZView 25DP-IOV-0072023-08-23
00850054345080eZView 28DP-IOV-0082023-08-23
00850054345097SurgiView 28DP-IOV-008-SS2023-08-23
00850054345103eZView 30DP-IOV-0092023-08-23
00850054345110eZView 40DP-IOV-0102023-08-23
00850054345127eZView 115P-IOV-0112023-08-23
00850054345134eZView 95P-IOV-0122023-08-23
00850054345141eZView 124 SPP-IOV-0132023-08-23
00850054345158eZView 22DP-IOV-0142023-08-23
00850054345165OmniView 137P-IOV-0152023-08-23
00850054345172OmniView 165P-IOV-0162023-08-23
00850054345189OmniView 145P-IOV-0172023-08-23
00850054345196OmniView 135P-IOV-0182023-08-23
00850054345202OmniView 85P-IOV-0192023-08-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
0081160801981920D Limited Edition #2VOLK OPTICAL INC.HJL2025-08-01
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
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
00850054345103eZView 30DIon Vision, IncHJL2023-08-23