Hanger Cranial Band 3D

GUDID 00859065006027

Cranial Remolding Orthosis

Symbiont Logistics, LLC

Cranial orthosis
Primary Device ID00859065006027
NIH Device Record Key6ef9b51f-04b0-430c-8dca-2b576a499087
Commercial Distribution StatusIn Commercial Distribution
Brand NameHanger Cranial Band 3D
Version Model NumberA8210
Company DUNS117545164
Company NameSymbiont Logistics, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100859065006027 [Primary]

FDA Product Code

MVAOrthosis, Cranial

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-01-03
Device Publish Date2024-12-26

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