AccessGUDID - DEVICE: OraStretch® Press Device

GUDID

Device Identifier (DI) Information

Brand Name: OraStretch® Press Device – Pediatric
Version or Model: CR1005
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Cranio Mandibular Rehab, Inc.

Primary DI Number: 00850056079037
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 048276773 *Terms of Use

Device Description: The OraStretch press system is indicated for individuals with, or at risk of trismus (limited oral opening) or jaw dysfunction. The appliance may also be used for physical therapy or rehabilitation of the mouth, jaw, or other orofacial tissues. The device is for single-patient use only. The Pediatric size is generally for patients under 10 years-old.

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?
17802	Mastication muscle exerciser	An intraoral mechanical exercise apparatus intended primarily to strengthen and rehabilitate the jaw muscles of mastication of a patient who has pain in, or disorders of, the temporomandibular joint (TMJ), typically through repetitive biting against resistive forces provided by the device. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ION	Exerciser, Non-Measuring

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
Width: 45 Millimeter

Device Record Status

Public Device Record Key: 9fbf0728-5478-4c45-88e3-c17a99dbf5b3
Public Version Date: October 13, 2023
Public Version Number: 1
DI Record Publish Date: October 05, 2023