AccessGUDID - DEVICE: AHIP Internal Trigger Point Wand (00862945000404)

GUDID

Device Identifier (DI) Information

Brand Name: AHIP Internal Trigger Point Wand
Version or Model: 1112
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NEW PELVIC PAIN TECHNOLOGIES

Primary DI Number: 00862945000404
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 031751981 *Terms of Use

Device Description: Therapeutic massager to internally massage trigger points in the pelvic floor musculature.

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?
65044	Pelvic floor internal manual massager	A manual (non-powered) device intended to be inserted into the rectum or vagina and manipulated to massage myofascial trigger points of the pelvic floor muscles to relieve acute or chronic pelvic pain (e.g., myofascial pelvic pain syndrome). It is in the form of a design-shaped plastic wand and is intended to be used with disposable coverings (not included) and a water-based lubricant (not included). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OSD	Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature

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: 1ea3ab02-bf4a-4535-8f3d-eef65fe82e1e
Public Version Date: December 07, 2023
Public Version Number: 1
DI Record Publish Date: November 29, 2023