AccessGUDID - DEVICE: Side Extension Board with Pad (Bariatric) (04946329207781)

GUDID

Device Identifier (DI) Information

Brand Name: Side Extension Board with Pad (Bariatric)
Version or Model: 08-086-24
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 08-086-24
Company Name: MIZUHO CORPORATION

Primary DI Number: 04946329207781
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690677802 *Terms of Use

Device Description: 90 mm Pad for Table Side Extension

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):	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?
35184	Operating table mattress, basic	A foam-filled cushion designed as a component of an operating table to serve as the surface upon which the patient is placed. It is typically filled with high-density polyurethane or a memory foam, and may be an integral part of the table (i.e., removable only with tools) or loosely fitted to the table top (e.g., by way of press studs, Velcro strips, or eyeholes and pegs) and is removable for cleaning. The device is firm, waterproof, and washable using strong disinfectants. It is available as one full-length piece or in sections. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GDC	Table, Operating-Room, Electrical

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
Length: 380 Millimeter

Device Record Status

Public Device Record Key: ce0c71e3-3ea6-4ef0-9437-6f471d85c19e
Public Version Date: April 25, 2022
Public Version Number: 1
DI Record Publish Date: April 15, 2022