AccessGUDID - DEVICE: CIRRUS HD-OCT (04057748087097)

GUDID

Device Identifier (DI) Information

Brand Name: CIRRUS HD-OCT
Version or Model: 500
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Carl Zeiss Meditec, Inc.

Primary DI Number: 04057748087097
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 362747011 *Terms of Use

Device Description: The CIRRUS™ HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device intended for in-vivo viewing, axial cross-sectional, and three-dimensional imaging of anterior and posterior ocular structures.

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:	No
Prescription Use (Rx):	No
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?
58850	Ophthalmic spectral-domain optical coherence tomography system	A mobile assembly of devices designed to use near infrared (NIR) LED light aimed into the eye to acquire, process, display and save in vivo depth-resolved images of anterior and posterior ocular tissue microstructures in clinical and perioperative examination through the use of interchangeable lenses. Spectral domain optical coherence tomography (SDOCT) is intended to aid in the diagnosis and evaluation of physiologic and pathologic conditions of the eye through non-contact optical imaging. Reflected light is picked up by a detector that converts it into electrical signals using a computer and dedicated software, providing cross-sectional or three-dimensional (3-D) volume scans for analysis.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OBO	Tomography, Optical Coherence

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K150977	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8ef6aead-9554-453b-aa47-0f69ea4d08f4
Public Version Date: June 05, 2020
Public Version Number: 4
DI Record Publish Date: August 25, 2016