AccessGUDID - DEVICE: Kaye Products

GUDID

Device Identifier (DI) Information

Brand Name: Kaye Products - TT2
Version or Model: TT2
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Kaye Products, Inc.

Primary DI Number: 00810117142711
Issuing Agency: GS1
Commercial Distribution End Date: April 30, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 082364654 *Terms of Use

Device Description: Large Tilting Table

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):	Yes
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?
31219	Ergonomic workdesk, manual	A manually-operated desk designed with ergonomic adjustments to provide improved personal work-position flexibility and to help prevent/reduce physical problems associated with sedentary work. It is intended to be used for work or training typically by patients with back problems or disabilities. It typically includes a mechanical height-adjustable worktop and may include tilting-functions or raised table edges; it is typically used for computer and writing work in an office, school, or home setting.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
INW	Table, Mechanical

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: 44d955b8-8656-47e0-803f-61dcfe066476
Public Version Date: May 12, 2025
Public Version Number: 2
DI Record Publish Date: July 05, 2023