AccessGUDID - DEVICE: FHC 1000 Radiographic Top O.R. Table (B337FHC10001)

GUDID

Device Identifier (DI) Information

Brand Name: FHC 1000 Radiographic Top O.R. Table
Version or Model: FHC1000K.1v03.1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FHC1000
Company Name: FUTURE HEALTH CONCEPTS, INC.

Primary DI Number: B337FHC10001
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 037304144 *Terms of Use

Device Description: Remote Control Operating Room Table With Radiographic Top Hi-Low 26 To 48 Trendelenburg 30 Degrees Reverse Trendelenburg 30 Degrees Side Tilt 20 Degrees Right To Left Back Section Up 80 Degrees (50 Degrees Down Reverse Orientation 80 Degrees Up 105 Degrees Down Flex Back Down 20 Degrees Maximum With Seat Down 25 Degrees Reflex Back Up 25 Degrees Return To Level Built-In Battery Back-Up Back Lit Hand Control 1000Lbs Weight Capacity. Patient Surface Is 77 3/4"" L X 203/4"" W. Overall Size Is 79"" L X 23""W. Electrical Specification Ac 110/120V/5A 300W. 50/60 Hz. Current Leakage . <100 Micro amps.

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?
35379	Universal operating table, electrohydraulic	A mobile, mains electricity (AC-powered) hydraulic-mechanism table designed to be adjusted to support a patient during many types of surgical interventions. The table surface consists of many articulated sections that can be elevated or lowered for contouring to accommodate numerous anatomical positions (e.g., the whole table top may be adjusted to form a curved surface) to satisfy the requirements of many clinical specialties.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FQO	Table, Operating-Room, Ac-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: b7bf661c-ebbc-426d-b1ee-1cdb19d5a02c
Public Version Date: December 10, 2018
Public Version Number: 1
DI Record Publish Date: November 08, 2018