FDA.reportPublic FDA data

Super View® Pack, Pivot Plus (40101+40227)

Primary DI
00852475007080
Brand
Super View® Pack, Pivot Plus (40101+40227)
Company
OCULUS SURGICAL INC
Model
40229
Catalog number
40229
Device description
1 Each SUPER VIEW® Pack, Pivot Plus & 1 Each 40101 Microscope Head Cover Drape
Published
2020-11-24
Public version status
Update
Distribution status
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
LROGeneral Surgery Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852475007097PackageGS18In Commercial Distribution
00852475007080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852475007097008524750070978524750070970852475007097
00852475007080008524750070808524750070800852475007080

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).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7722362622sales@oculussurgical.com
7722362622info@oculussurgical.com

Regulatory Flags#

DUNS number
015409582
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856222004025SUPER VIEW® Pack40211402112016-09-23
00856222004728HD LenZ Pack Plus, for ZEISS RESIGHT®54019540192020-11-24
00856222004018SUPER VIEW® Pack40213402132016-09-23
00856222004209SUPER VIEW Lens, Disposable Contact, Tornambe40413404132024-08-13
10856222004206SUPER VIEW Lens, Disposable Contact, Tornambe40413404132024-08-13
00852475007042SUPER VIEW® Lens Set, HD Plus, Disposable for ZEISS RESIGHT®40240402402020-11-24
00852475007103HD LenZ Pack for ZEISS RESIGHT®54010540102020-11-24
00852475007127BIOM Optic Set, HD Professional, for f=175mm54021540212022-02-15
00852475007141BIOM Optic Set, HD Professional, for f=200mm54022540222022-02-15
00852475007165HD Disposable, LenZ54026540262022-02-15
00852475007240Versa Optic Set, for f=200mm54212542122022-01-25
00852475007264VERSA HD Disposable LenZ542162020-12-04
00856222004056SUPER VIEW® Disposable Lens Set, Essential40403404032016-09-23
00856222004179SUPER VIEW® Disposable Lens Set, Pivot Plus40227402272016-09-23
00856222004544SUPER VIEW® Disposable HD Lens Set for RESIGHT®40220402202020-11-24
00856222004551SUPER VIEW Pack, HD, Disposable, for ZEISS RESIGHT®54018540182020-11-24
00856222004742SUPER VIEW® Disposable Lens Set, Pivot40223402232016-09-23
00852475007158BIOM Optic Set, HD Flex54025540252022-02-15
00852475007219Versa Optic Set, for f=175mm54211542112022-01-25
00852475007189Super View® Lens Set, Disposable, Pivot, for BIOM ml/cl54014540142020-11-24

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Primary DI, Brand, Company table
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10809160527474HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527481HalyardAVID MEDICAL, INC.LRO2026-07-17
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