AccessGUDID - DEVICE: HarmonyAIR (00724995193782)

GUDID

Device Identifier (DI) Information

Brand Name: HarmonyAIR
Version or Model: A-Series Non-Sterilizable Light Handle
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: LAS0038
Company Name: STERIS CORPORATION

Primary DI Number: 00724995193782
Issuing Agency: GS1
Commercial Distribution End Date: May 18, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 036985604 *Terms of Use

Device Description: The Non-Sterilizable Plastic Light Handle is used with the HarmonyAIR A-Series Lighting System.

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):	No
Over the Counter (OTC):	Yes
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?
44975	Medical equipment handle cover, reusable	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 rigid 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 reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MDM	INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

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: da4f2b27-eaa0-46f2-a373-f5bc7dca7fb1
Public Version Date: May 18, 2021
Public Version Number: 4
DI Record Publish Date: May 28, 2020