AccessGUDID - DEVICE: OPTIVISOR BINOCULAR MAGNIFIER (00192896053144)

GUDID

Device Identifier (DI) Information

Brand Name: OPTIVISOR BINOCULAR MAGNIFIER
Version or Model: 1103-4001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1103-4001
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: 00192896053144
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use

Device Description: OPTIVISOR BINOCULAR MAGNIFIER #DA-7

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?
32692	Surgical binoculars, reusable	A pair of lenses intended to be mounted onto a surgeon's spectacles to function as small telescope and provide a magnified image of the visual field during patient examination or surgical intervention. Also known as a surgical loupe, it may be mounted onto the spectacle frames and positioned in front of the spectacle lenses or attached directly onto each of the spectacle lenses. It may also be connected to an external light source or a head-worn light for visual field illumination. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FSP	Loupe, Diagnostic/Surgical

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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
High-level Disinfectant

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 2.7 Maginification at 8 Inches

Device Record Status

Public Device Record Key: 911613b8-98ab-4d57-bedb-21348a146e78
Public Version Date: June 11, 2019
Public Version Number: 2
DI Record Publish Date: September 24, 2018