AccessGUDID - DEVICE: Fiber Optic Light Guide (00853480006082)

GUDID

Device Identifier (DI) Information

Brand Name: Fiber Optic Light Guide
Version or Model: Wide Angle, 20 ga, Universal
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TR9821-11
Company Name: ESCALON MEDICAL CORP.

Primary DI Number: 00853480006082
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 879144426 *Terms of Use

Device Description: Wide angle fiber optic light probe for wide view intraocular illumination. Wide angle light guide, 20 ga, with Universal connector. Sterile, single-use.

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:	Yes
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?
45193	Ophthalmic fibreoptic light instrument, single-use	A sterile, hand-held, ophthalmic surgical instrument with a thin, rigid, insertion portion, that is inserted into the eye during a surgical intervention for the purpose of conducting a field of cold light to the posterior segment of the eye. It is connected through a permanently attached light cable to a light source. It has a fibreoptic bundle core that conducts the light, and may be provided with an atraumatic tip to allow for extraocular manipulation (orbital depression) with transscleral illumination. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FST	Light, Surgical, Fiberoptic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K875195	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 02f08b13-0519-4899-baee-ed927b09b97f
Public Version Date: May 07, 2019
Public Version Number: 4
DI Record Publish Date: January 14, 2016