FDA.reportPublic FDA data

SUPER VIEW® Pack for ZEISS RESIGHT®

Primary DI
00856222004834
Brand
SUPER VIEW® Pack for ZEISS RESIGHT®
Company
INSIGHT INSTRUMENTS, INC.
Model
TS-RP-7001
Catalog number
40224
Device description
1 Each 40226 ZEISS RESIGHT® Disposable Lens Set & 1 Each ZEISS RESIGHT® Headcover Drape. Distributed by THEA Surgical (Insight's REF 40224)
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#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10856222004831PackageGS18In Commercial Distribution
00856222004834PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085622200483110856222004831
00856222004834008562220048348562220048340856222004834

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

Contacts#

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

Regulatory Flags#

DUNS number
828348391
Device count
1
Kit
true
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
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
10856222004657SUPER VIEW® Disposable Wide Field Lens for ZEISS RESIGHT®TS-ZR-SV404242016-09-23