AccessGUDID - DEVICE: SurgiLight Disposable Handle Assembly (10865082000174)

GUDID

Device Identifier (DI) Information

Brand Name: SurgiLight Disposable Handle Assembly
Version or Model: 2816-01-0002
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BihlerMed, L.L.C.

Primary DI Number: 10865082000174
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 828549936 *Terms of Use

Device Description: The Disposable Handle Assembly is a sub-assembly of the View Medical SurgiLight. The Disposable Handle Assembly attaches to the SurgiLight and is essential to the overall functionality of the surgical light. The dual purpose handle gives the user the ability to focus the light by rotating the handle and serves as a layer of protection for the light-emitting diode (LED) housing. The medical cover sleeve is extended over the SurgiLight to provide a sterile barrier to the flexible shaft.

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":	Yes
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?
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

FDA Product Code

[?]

Product Code	Product Code Name
FTA	Light, Surgical, Accessories

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5b33c8cc-a56c-42ab-a512-b14eab8c4b6b
Public Version Date: November 06, 2023
Public Version Number: 3
DI Record Publish Date: August 09, 2019