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OraMPA™ Static Wrap Pack

FDA UDI

Class I (US FDA UDI)

by CranioMandibular Rehab, Inc.

Identity

Trade Name
OraMPA™ Static Wrap Pack FDA UDI
Generic Name
Mastication muscle exerciser FDA UDI
Device Name
The OraMPA static wraps fit on the OraMPA device for static holds of the mouthpieces. FDA UDI
Model / Reference
CR1743 FDA UDI
Description
The OraMPA static wraps fit on the OraMPA device for static holds of the mouthpieces. FDA UDI

Identifiers

Primary DI / UDI-DI
00850056079167 FDA UDI
FDA Product Code
ION FDA UDI
GMDN Term
Mastication muscle exerciser FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.5370 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Mastication muscle exerciser

OraMPA™ Static Wrap Pack by CranioMandibular Rehab, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mastication muscle exerciser.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
CranioMandibular Rehab, Inc.

Sources (1)

  • FDA UDI 6283b50a-617a-484d-a1f1-a6c30e7ba4c8 34 fields · synced Jun 9, 2026