Bone Marrow Access Needle with Sheath - 25x Max

GUDID 00810131881108

SURGENTEC, LLC

Bone marrow biopsy procedure kit
Primary Device ID00810131881108
NIH Device Record Key1370d259-cb95-457d-88f1-b0cd84c08eba
Commercial Distribution StatusIn Commercial Distribution
Brand NameBone Marrow Access Needle with Sheath - 25x Max
Version Model NumberSR07-1925
Company DUNS004095409
Company NameSURGENTEC, 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 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
GS100810131881108 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PDQNeurosurgical Nerve Locator

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-01-13
Device Publish Date2025-01-03

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