AccessGUDID - DEVICE: HEINE OMEGA 180 (00192896009493)

GUDID

Device Identifier (DI) Information

Brand Name: HEINE OMEGA 180
Version or Model: C-004.33.503
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: C-004.33.503
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: 00192896009493
Issuing Agency: GS1
Commercial Distribution End Date: January 04, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use

Device Description: HEINE - OMEGA 500 UNPLUGGED WITH HC50 L HEADBAND

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?
15652	Loupe	A convex lens with an built-in, electrical light source used for magnifying vision and concentrating the light upon an object or objects being viewed. It can be used for a variety of purposes, e.g., the examination of an object for laboratory work, diagnosis, minor surgery, dermatology, or by persons with a strong eyesight impairment. The loupe is typically mounted on the end of an adjustable arm (e.g., a flexible tube or an articulating arm) which is attached to a stable base or clamped to a surface worktop.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HJI	Lens, Fundus, Hruby, Diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K123316	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization
Dry Heat Sterilization

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: f45f06b9-dabf-441f-96df-3188d035f68b
Public Version Date: April 08, 2024
Public Version Number: 3
DI Record Publish Date: August 15, 2018