AccessGUDID - DEVICE: Leander (G509SERIES9500)

GUDID

Device Identifier (DI) Information

Brand Name: Leander
Version or Model: LT-950
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Leander, LLC

Primary DI Number: G509SERIES9500
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117963502 *Terms of Use

Device Description: Examination/treatment motorized table with some articulated sections that can be adjusted into various accommodations for patient comfort and/or treatment. The height of the table surface is also power-adjusted. It is typically used by physical therapists and chiropractors.

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):	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?
31362	Examination/treatment table, line-powered	A mobile, mains electricity (AC-powered) motorized table designed for routine/minor medical examinations and/or treatment of the patient. It will typically consist of a framework or a large pedestal with a flat table top surface which consists of some articulated sections that can be adjusted into a raised position. The height of the table top surface will also be power-adjusted. It is typically used in examination rooms, endoscopy facilities, electrophysiology (EP) laboratories, or outpatient departments for minor interventions.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LGX	Table, Examination, Medical, Powered

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: 08f33d15-1e9e-4e70-89c5-8747bdd17c0a
Public Version Date: February 27, 2024
Public Version Number: 1
DI Record Publish Date: February 19, 2024