Back-N-Black Low Profile

GUDID 00802357632459

MEDICAL SPECIALTIES INCORPORATED

Lumbar spine orthosis
Primary Device ID00802357632459
NIH Device Record Keyf5549883-df86-41f6-acb6-40df787c8d9c
Commercial Distribution StatusIn Commercial Distribution
Brand NameBack-N-Black Low Profile
Version Model Number163245
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
GS100802357632459 [Primary]

FDA Product Code

IPYOrthosis, Lumbo-Sacral

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 [Back-N-Black Low Profile]

00802357632473163247
00802357632466163246
00802357632459163245
00802357632442163244
00802357632411163241
00080235763208163242
00802357632428163242

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