AccessGUDID - DEVICE: View Medical SurgiLight (10865082000181)

GUDID

Device Identifier (DI) Information

Brand Name: View Medical SurgiLight
Version or Model: 2816-01-0001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BihlerMed, L.L.C.

Primary DI Number: 10865082000181
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 828549936 *Terms of Use

Device Description: The SurgiLight by View Medical is a surgical lighting system that aims to provide surgeons with a safe and practical illumination device to focus on specific target areas. It mounts to the handle attachment anchor point of various overhead surgical lights, and features a long, flexible shaft that will allow the user to direct the light onto the incision from any desired angle. The View Medical SurgiLight shall be used in conjunction with the sterile Disposable Handle Assembly.

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:	Yes
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?
44977	Medical equipment handle cover, single-use	A device designed specifically to cover the handle of a piece of medical equipment (e.g., operating light) to provide a physical sterile barrier between the handle and the hand of a healthcare professional, e.g., during a surgical procedure. It is typically a polymer device designed for attachment to a handle and may in addition provide grip for improved manipulation of the handle; it is not designed to cover other equipment components. This is a single-use device.	Active	false
12282	Operating room light	A device designed to provide a specialized source of light for illumination of a site of medical intervention. It provides a high intensity, high colour rendering field of light that minimizes shadows and the emission of heat. It typically consists of an individual light head with more than one light source which may include halogen bulbs or light-emitting diodes (LEDs), reflectors, mirrors and a mechanism to adjust the focus. This device is usually mounted to the ceiling or wall of an operating room (OR) and the mount may be included. It can be part of an OR light system comprising more than one light head.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FTA	Light, Surgical, Accessories
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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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: 877370e1-8b3a-4848-af50-b5ec7beee8f0
Public Version Date: November 06, 2023
Public Version Number: 4
DI Record Publish Date: August 05, 2019