AccessGUDID - DEVICE: NUVO PADS (00816835023370)

GUDID

Device Identifier (DI) Information

Brand Name: NUVO PADS
Version or Model: B2DCP001630
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Medical Illumination International Inc.

Primary DI Number: 00816835023370
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 093357739 *Terms of Use

Device Description: Head Section Pad

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
FWZ	Operating Room Accessories Table Tray

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: 32186a0f-8a9e-4dde-9024-663b1b81ba3e
Public Version Date: September 19, 2022
Public Version Number: 2
DI Record Publish Date: March 31, 2020