AccessGUDID - DEVICE: Single-use lenses for RESIGHT, MACULA LENS (04049539106704)

GUDID

Device Identifier (DI) Information

Brand Name: Single-use lenses for RESIGHT, MACULA LENS
Version or Model: 302721-9107-000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Carl Zeiss Meditec AG

Primary DI Number: 04049539106704
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 342228620 *Terms of Use

Device Description: Single- use lenses for RESIGHT are ophthalmic surgical microscope lenses used in combination with the ZEISS RESIGHT fundus viewing system. The fundus viewing system is an accessory for surgical microscopes which is used for surgery on the posterior segment of the eye. It is used for stereoscopic imaging of the posterior segment and the retina.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
67065	Ophthalmic surgical microscope lens	A lens intended to be used with an ophthalmic surgical microscope to facilitate stereoscopic imaging during posterior segment surgery. The lens is typically attached to the parent device such that it enters the surgical field, however is not intended for patient contact. It may be available in a variety of sizes and optical powers. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HRM	Microscope, Operating & Accessories, Ac-Powered, Ophthalmic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Special Storage Condition, Specify: The product must be stored in a dry environment shielded from direct sunlight and within a temperature range of +10 °C to +35 °C.

Clinically Relevant Size

[?]

Size Type Text
Width: 23 Millimeter
Height: 24 Millimeter
Length: 40 Millimeter

Device Record Status

Public Device Record Key: 52bb14f7-2bd8-48c3-b216-60a200e6c016
Public Version Date: November 15, 2024
Public Version Number: 1
DI Record Publish Date: November 07, 2024