AccessGUDID - DEVICE: KLARO In Vivo Surgical Lighting (08881300212001)

GUDID

Device Identifier (DI) Information

Brand Name: KLARO In Vivo Surgical Lighting
Version or Model: 555-01-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 555-01-01
Company Name: VIVO SURGICAL PRIVATE LIMITED

Primary DI Number: 08881300212001
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 659504181 *Terms of Use

Device Description: KLARO is a deep-cavity surgical LED lighting device for open surgery use. It is discreet, easy to use and provides bright, uniform and localised "flood-lighting" from within the surgical site. KLARO maintains a safe and cool working temperature suited for use inside the human body regardless of the luminous intensity selected.

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):	No
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?
65349	Open surgical site internal light	An electrically-powered, light-emitting device that includes a light source and is intended to be placed within, or nearly within, a surgical wound/site for illumination during open surgery. It may be fixed to a surgical instrument (e.g., a retractor) and typically operates with either fibreoptic or LED technology to create cold light. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FTD	Lamp, 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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 40 and 70 Percent (%) Relative Humidity
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: 67aff76c-1ccd-4a78-92f4-c7cd35ae415b
Public Version Date: March 21, 2023
Public Version Number: 1
DI Record Publish Date: March 13, 2023