AccessGUDID - DEVICE: Hayden Medical (00840319716489)

GUDID

Device Identifier (DI) Information

Brand Name: Hayden Medical
Version or Model: LS-300LED
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LS-300LED
Company Name: Hayden Medical, Inc.

Primary DI Number: 00840319716489
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 618214410 *Terms of Use

Device Description: LED Light Source, comparable to most 300w Xenon, with 4 port turret (ACMI, Wolf, Storz and Olympus) Color temperature:6500°K @ 75 CRI or 5600°K @ 92 CRI. Expected LED life of 30,000 hours

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?
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
NTN	Led light source

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 [?]
Moist Heat or Steam 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: 8ddf50c3-a12f-48fa-b67a-7bf9db79c03a
Public Version Date: August 11, 2022
Public Version Number: 1
DI Record Publish Date: August 03, 2022