AccessGUDID - DEVICE: ENOCHS Examining Room Furniture (M1174520060)

GUDID

Device Identifier (DI) Information

Brand Name: ENOCHS Examining Room Furniture
Version or Model: 4520-06
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4520-06
Company Name: ENOCHS MANUFACTURING INC

Primary DI Number: M1174520060
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 042826131 *Terms of Use

Device Description: Low access high-low table is designed for use in hospitals, clinics and private physician examination rooms. Table has positioning capability to adjust table height and back section of the upholstered couch section by use of a foot control and/or hand control. Low access high-low table is intended to be used for general examinations by qualified medical professionals to position and support patients during procedures.

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?
38447	General examination/treatment chair, electric	A mains electricity (AC-powered) device designed to support and position the patient in a seated or reclined posture for easy access and patient comfort during a diagnostic examination, medical treatment, and/or surgical procedure across specialties. It usually has moveable components and may include special features such as a raising and lowering mechanism and removable arms; it may have an integrated weighing scale. For chairs involving the use of medical systems that emit and/or detect energy (e.g., ionizing or non-ionizing radiation, ultrasound, heat, light) see the respective chair terms for those systems.	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: 21d13fa9-5c05-453d-a98d-4c7fa3037f6d
Public Version Date: July 23, 2020
Public Version Number: 1
DI Record Publish Date: July 15, 2020