AccessGUDID - DEVICE: iPac® Pachymeter (00812559011228)

GUDID

Device Identifier (DI) Information

Brand Name: iPac® Pachymeter
Version or Model: 16040
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: REICHERT, INC.

Primary DI Number: 00812559011228
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 126650253 *Terms of Use

Device Description: Handheld, battery-powered, ultrasound device intended to measure the thickness of the cornea. The device tip is touched to a patient's eye during the measurement.

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):	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?
16330	Ultrasound pachymeter	A mains electricity (AC-powered), ophthalmic device designed to use ultrasound to measure the thickness of the cornea, and may in addition be designed to measure axial length and anterior chamber depth. A small ultrasound probe(s) that is connected to this device is placed directly onto the cornea to make the measurements which are recorded and displayed by the pachymeter. The data is used to evaluate refractive eye surgery [e.g., laser assisted in situ keratomileusis (LASIK) treatment], evaluate ocular measurements for calculating intraocular lens power, monitor epithelium regrowth, and for other ophthalmic measurement evaluations.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYO	System, Imaging, Pulsed Echo, Ultrasonic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K030610	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: cebfa8cd-5cf3-41bf-b636-19aa8a535c41
Public Version Date: July 06, 2018
Public Version Number: 4
DI Record Publish Date: September 22, 2016