Micro Orca™ AB-7200

GUDID 00854629006994

Micro Orca™

DUNAMIS MEDICAL, LLC

Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button Orthopaedic fixation suture button
Primary Device ID00854629006994
NIH Device Record Key7d6ca520-505b-4827-9718-69f577441b83
Commercial Distribution StatusIn Commercial Distribution
Brand NameMicro Orca™
Version Model NumberAB-7200
Catalog NumberAB-7200
Company DUNS079471560
Company NameDUNAMIS MEDICAL, 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
GS100854629006994 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HTNWasher, Bolt Nut

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-24
Device Publish Date2023-08-16

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