AccessGUDID - DEVICE: PAL650 Pressure feeler 650g (03760262492933)

GUDID

Device Identifier (DI) Information

Brand Name: PAL650 Pressure feeler 650g
Version or Model: PAL650
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 103611
Company Name: SEDATELEC

Primary DI Number: 03760262492933
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 266031462 *Terms of Use

Device Description: The Palpeur is a device for pressure applying. The pressure feeler is intended to produce stimulation of reflex points or skin areas of the auricular pinna by the application of variable pressure.

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?
34009	External manual massager, clinical	A manual (non-powered) device designed to apply external massage to a patient, by the patient, staff, or a therapist in a hospital, institution, or therapeutic treatment situation. It is intended to stimulate/massage body muscles to provide a therapeutic effect. It is typically designed to be held in the hands and is available in a variety of configurations and materials, e.g., plastic, wood, ceramics. It is available in a variety of sizes and shapes and may be a one-piece device or have interchangeable massaging components (e.g., roller heads or pads), and have a variety of massage surfaces (e.g., points, ribs, smooth). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNM	Device, Pressure Applying

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: 31688214-2ce8-469d-9111-27fac2e208af
Public Version Date: May 03, 2024
Public Version Number: 1
DI Record Publish Date: April 25, 2024