SteriSpine VA

GUDID 08800038039438

MEDINAUT Plus

IMEDICOM CO., LTD.

Orthopaedic cement preparation/delivery kit
Primary Device ID08800038039438
NIH Device Record Keyc5474b7d-f625-472b-8210-c3406d83ef2c
Commercial Distribution StatusIn Commercial Distribution
Brand NameSteriSpine VA
Version Model NumberSPICD-CA2/ SPICD-NDD2
Company DUNS690340653
Company NameIMEDICOM CO., LTD.
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800038039438 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRXArthroscope

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-10-02
Device Publish Date2025-09-24

On-Brand Devices [SteriSpine VA ]

08800038039476MEDINAUT Plus
08800038039469MEDINAUT Plus
08800038039452MEDINAUT Plus
08800038039445MEDINAUT Plus
08800038039438MEDINAUT Plus
08800038039421MEDINAUT Plus
08800038039414MEDINAUT Plus
08800038039407MEDINAUT Plus
08800038029422MEDINAUT Plus
08800038029415MEDINAUT Plus
08800038029378MEDINAUT Plus
08800038029361MEDINAUT Plus
08800038029354MEDINAUT Plus
08800038029347MEDINAUT Plus
08800038029330MEDINAUT Plus
08800038029323MEDINAUT Plus

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