FDA.reportPublic FDA data

OraStretch® Deflection Deviation Scales

Primary DI
00850056079105
Brand
OraStretch® Deflection Deviation Scales
Company
Cranio Mandibular Rehab, Inc.
Model
CR1083
Catalog number
CR1083
Device description
The OraStretch Deflection Deviation Scales measure the opening and range-of-motion of the mouth.
Published
2024-04-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IONExerciser, Non-Measuring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IONExerciser, Non-MeasuringPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850056079105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850056079105008500560791058500560791050850056079105

GMDN Terms#

Term, Definition table
TermDefinition
Mastication muscle exerciserAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-206-8381support@craniorehab.com

Regulatory Flags#

DUNS number
048276773
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850056079051OraStretch® Bitepad Pack – StandardCR10502024-04-01
00850056079068OraStretch® Bitepad Pack – StandardCR10552024-04-01
00850056079075OraStretch® Bitepad Pack – StandardCR10572024-04-01
00850056079082OraStretch® Power Band PackCR1070CR10702024-04-01
00850056079099OraStretch® Jaw ROM Scale PackCR1080CR10802024-04-01
00850056079129OraStretch® Jaw MIO Plastic ScaleCR1087CR10872024-04-01
00850056079136OraMPA™ Microstomia ApplianceCR17302024-04-01
00850056079143OraMPA™ Microstomia Appliance - Severe Extra SmallCR17352024-04-01
00850056079150OraMPA™ Dynamic Band PackCR17412024-04-01
00850056079167OraMPA™ Static Wrap PackCR17432024-04-01
00850056079396OraStretch® Jaw MIO Scale PackCR1085CR10852024-04-01
00850056079402OraMPA™ Microstomia Appliance - XL Semi-CircumferentialCR17332024-04-01
00850056079006OraStretch® Press Device – StandardCR10002023-10-05
00850056079020OraStretch® Press Device – AnteriorCR10032023-10-05
00850056079037OraStretch® Press Device – PediatricCR10052023-10-05
00850056079044OraStretch® Extended Clip-On MouthpieceCR1007CR1007X2023-10-05

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