FDA.reportPublic FDA data

SUPER VIEW® Pack

Primary DI
00856222004025
Brand
SUPER VIEW® Pack
Company
OCULUS SURGICAL INC
Model
40211
Catalog number
40211
Device description
1 Each 40411 Sterile Disposable SUPER VIEW® Lens Set & 1 Each 40100 Sterile Microscope Drape
Published
2016-09-23
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
10856222004022PackageGS18In Commercial Distribution
00856222004025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085622200402210856222004022
00856222004025008562220040258562220040250856222004025

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment/instrument drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter13Millimeter
Outer Diameter18Millimeter
Outer Diameter42Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius50 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
772-236-2622info@oculussurgical.com

Regulatory Flags#

DUNS number
015409582
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00852475007080Super View® Pack, Pivot Plus (40101+40227)40229402292020-11-24
00852475007189Super View® Lens Set, Disposable, Pivot, for BIOM ml/cl54014540142020-11-24

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