Phantom Dorsal NIght Splint with Toe Strap

GUDID 00802357000197

MEDICAL SPECIALTIES INCORPORATED

Foot orthosis
Primary Device ID00802357000197
NIH Device Record Keyf3908d03-88af-4974-987a-b69c5c282ddc
Commercial Distribution StatusIn Commercial Distribution
Brand NamePhantom Dorsal NIght Splint with Toe Strap
Version Model Number264126-T
Company DUNS003173028
Company NameMEDICAL SPECIALTIES INCORPORATED
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100802357000197 [Primary]

FDA Product Code

ITWJoint, Ankle, External Brace

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-15
Device Publish Date2022-12-07

On-Brand Devices [Phantom Dorsal NIght Splint with Toe Strap]

00802357000203264127-T
00802357000197264126-T
00802357000180264125-T
00802357000173264124-T
00802357000166264122-T

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