AccessGUDID - DEVICE: WOTURE (B845CBZ041)

GUDID

Device Identifier (DI) Information

Brand Name: WOTURE
Version or Model: CBZ04
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Intco Medical Industries, Inc.

Primary DI Number: B845CBZ041
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080162537 *Terms of Use

Device Description: Functional and sleek with height-adjustable design for reading/working, smooth-rolling casters. Easy assembly for bedrooms, dorms, or small spaces.

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?
38458	Examination/treatment table, manual	A non-mobile table designed for routine/minor medical examinations and/or treatment of the patient. It will typically consist of a framework with a flat table top surface which may have a head section that can be manually adjusted into a raised position. The height of the table may also be manually adjusted to fixed positions (i.e., set to an initial height but not readily adjustable). It may facilitate a paper roll holder from which paper is pulled to cover the table surface as a hygienic barrier for each new patient. This device is typically used in examination rooms or doctors' surgeries as a statically placed table.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KMN	Chair And Table, Medical

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: a2f27063-600c-4e01-bb07-9494378bb17b
Public Version Date: March 28, 2025
Public Version Number: 1
DI Record Publish Date: March 20, 2025