AccessGUDID - DEVICE: HEINE MPACK COMPLETE (B099X007996720)

GUDID

Device Identifier (DI) Information

Brand Name: HEINE MPACK COMPLETE
Version or Model: X-007.99.672
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: B099X007996720
Issuing Agency: HIBCC
Commercial Distribution End Date: September 23, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use

Device Description: HEINE MPACK COMPLETE WITH TRANSFORMER

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?
46790	Indirect binocular ophthalmoscope	An electrically-powered, head-worn, ophthalmic instrument designed to be held arm’s length from the patient to examine the interior of the eye and related structures [e.g., fundus (retina), cornea, aqueous, lens, vitreous] using the examiner’s two eyes simultaneously (stereoscopic vision). It is intended to provide a wide field of view and produce an inverted (reversed) image of approximately 2 to 5 times magnification. It typically consists of a main light to illuminate the interior of the eyeball, lenses, filters and an illuminator beam to eliminate reflexes; it can be mounted on a headband or spectacle frames.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HLJ	Ophthalmoscope, Battery-Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K142486	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
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: 9cad43fb-5ae5-4519-a5c0-fa2a603d1e39
Public Version Date: February 19, 2021
Public Version Number: 7
DI Record Publish Date: August 08, 2017