BMAC Bevel Needle Assembly

GUDID 00810131881047

SURGENTEC, LLC

Bone marrow biopsy procedure kit
Primary Device ID00810131881047
NIH Device Record Key37b4a9ab-d17d-42f0-91c5-eeeb1637d1c5
Commercial Distribution StatusIn Commercial Distribution
Brand NameBMAC Bevel Needle Assembly
Version Model NumberSR07-1400
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
GS100810131881047 [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

Devices Manufactured by SURGENTEC, LLC

00810131881375 - ALARA 11 Gauge Access Needle with Sheath - Bevel Tip2025-05-07
00810131881382 - ALARA 11 Gauge Access Needle with Sheath - Diamond Tip2025-05-07
00850040139471 - ALARA® 11 Gauge Access Needle - Bevel Tip2025-05-07
00850040139488 - ALARA® 11 Gauge Access Needle - Diamond Tip2025-05-07
00850040139495 - ALARA® 11 Gauge Access Needle Two Pack- Bevel Tip2025-05-07
00850040139501 - ALARA® 11 Gauge Access Needle Two Pack- Diamond & Bevel Tip2025-05-07
00850040139518 - ALARA® 11 Gauge Access Needle Two Pack- Diamond Tip2025-05-07
00850040139525 - ALARA® 11 Gauge Access Needle with Sheath - Bevel Tip2025-05-07

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