Hanger Cranial Band 3D

FDA UDI

Class II (US FDA UDI)

by Symbiont Logistics, LLC

Identity

Trade Name: Hanger Cranial Band 3D FDA UDI
Generic Name: Cranial orthosis FDA UDI
Device Name: Cranial Remolding Orthosis FDA UDI
Model / Reference: A8210 FDA UDI
Description: Cranial Remolding Orthosis FDA UDI

Identifiers

Primary DI / UDI-DI: 00859065006027 FDA UDI
FDA Product Code: 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

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Cranial orthosis

Hanger Cranial Band 3D by Symbiont Logistics, LLC — 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: Symbiont Logistics, LLC

Sources (1)

FDA UDI 6ef9b51f-04b0-430c-8dca-2b576a499087 33 fields · synced Jun 1, 2026