DEVICE: SUPER VIEW® Pack for ZEISS RESIGHT® (00856222004841)
Device Identifier (DI) Information
SUPER VIEW® Pack for ZEISS RESIGHT®
TS-RP-7002
In Commercial Distribution
40225
INSIGHT INSTRUMENTS, INC.
TS-RP-7002
In Commercial Distribution
40225
INSIGHT INSTRUMENTS, INC.
1 Each 40226 ZEISS RESIGHT® Disposable Lens Set & 1 Each ZEISS RESIGHT® Full Body Drape. Distributed by THEA Surgical (Insight's REF 40225)
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| Yes | |
| Yes | |
| Yes | |
| No | |
| Yes | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 12535 | Medical equipment drape, single-use |
A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.
|
Active | false |
| 47946 | Ophthalmic diagnostic condensing lens |
An ophthalmic lens intended to be used during binocular indirect ophthalmoscopy and/or slit lamp examination to focus reflected light from the fundus of the eye. The lens is available in a variety of sizes and optical powers. This is a reusable device.
|
Active | false |
| 58070 | Vitrectomy contact lens, single-use |
A sterile ophthalmic lens intended to be placed on the cornea of a patient to improve visualization of the fundus and retinal structures by surgical staff using an ophthalmic microscope during vitreoretinal surgery. Also known as a vitrectomy sutureless lens (VSL), it is made of various transparent materials [e.g., polymethylmethacrylate (PMMA), glass, quartz]. This is a single-use device.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| No Product Codes | |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Outer Diameter: 13 Millimeter |
| Outer Diameter: 18 Millimeter |
Device Record Status
f5a8bbda-a91c-4980-9d9e-488cc725d8e2
June 17, 2022
6
September 23, 2016
June 17, 2022
6
September 23, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| 10856222004848 | 8 | 00856222004841 | In Commercial Distribution | Case |
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
(772) 219-9393
CustomerService@InsightInstruments.com
CustomerService@InsightInstruments.com