Michigan Cranial Reshaping Orthosis

FDA UDI

Class II (US FDA UDI)

by Danmar Products, Inc.

Identity

Trade Name: Michigan Cranial Reshaping Orthosis FDA UDI
Generic Name: Cranial orthosis FDA UDI
Device Name: The Danmar Products Michigan Cranial Reshaping Orthosis is intended for prescription use to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants from 3 to 18 months of age with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic- and brachycephalic-shaped heads. FDA UDI
Model / Reference: 9841 FDA UDI
Description: The Danmar Products Michigan Cranial Reshaping Orthosis is intended for prescription use to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants from 3 to 18 months of age with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic- and brachycephalic-shaped heads. FDA UDI

Identifiers

Primary DI / UDI-DI: 00862948000302 FDA UDI
510(k) Number: K003630 FDA UDI
K090341 FDA UDI
FDA Product Code: OAN FDA UDI
MVA FDA UDI
GMDN Term: Cranial orthosis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.5970 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

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Lot / Batch Number

FDA UDI

Serial Number

Yes

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Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Cranial orthosis

Michigan Cranial Reshaping Orthosis by Danmar Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Danmar Products, Inc.

Sources (1)

FDA UDI d2218c71-99d9-4e29-8a06-06fe4e778ee5 35 fields · synced Jun 1, 2026