Spine Needle (16 Gauge)

GUDID 00846338001315

ELLIQUENCE, LLC

Rigid endoscopic cannula, single-use
Primary Device ID00846338001315
NIH Device Record Key75a2288f-6a48-4632-a05f-8199d4b0cc3c
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpine Needle (16 Gauge)
Version Model NumberDFX-N6/1
Company DUNS019872358
Company NameELLIQUENCE, 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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100846338001315 [Package]
Contains: 00846338008017
Package: Box (DFX-N6) [10 Units]
In Commercial Distribution
GS100846338008017 [Primary]

FDA Product Code

BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-22

Devices Manufactured by ELLIQUENCE, LLC

00846338000776 - Spine Needle (18 Gauge)2019-07-22
00846338000066 - Trigger-Flex®2019-04-23 S 36cm
00846338000288 - Trigger-Flex®2019-04-23
00846338000448 - Bi-Tip™ Flextrode™2019-04-23
00846338000455 - Trigger-Flex®2019-04-23
00846338000462 - Micro Bipolar2019-04-23
00846338000479 - Micro Bipolar2019-04-23
00846338000486 - Bi-Tip™ Flextrode™2019-04-23

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