BNX N-25-05

GUDID 00855208005070

FINE NEEDLE ASPIRATION NEEDLE

Covidien LP

General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use
Primary Device ID00855208005070
NIH Device Record Key1f9a9be8-029a-4510-a3ec-47b7b84369de
Commercial Distribution StatusIn Commercial Distribution
Brand NameBNX
Version Model NumberN-25-05
Catalog NumberN-25-05
Company DUNS058614483
Company NameCovidien LP
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

Customer Support Contacts

Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Needle Gauge25 Gauge
Device Size Text, specify0
Needle Gauge25 Gauge
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Needle Gauge25 Gauge
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Needle Gauge25 Gauge
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Needle Gauge25 Gauge
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Needle Gauge25 Gauge
Device Size Text, specify0
Needle Gauge25 Gauge
Device Size Text, specify0
Needle Gauge25 Gauge
Device Size Text, specify0
Needle Gauge25 Gauge
Device Size Text, specify0
Needle Gauge25 Gauge
Device Size Text, specify0
Needle Gauge25 Gauge
Device Size Text, specify0
Needle Gauge25 Gauge
Device Size Text, specify0
Needle Gauge25 Gauge
Device Size Text, specify0
Needle Gauge25 Gauge
Device Size Text, specify0
Needle Gauge25 Gauge
Device Size Text, specify0
Needle Gauge25 Gauge
Device Size Text, specify0
Needle Gauge25 Gauge
Device Size Text, specify0
Needle Gauge25 Gauge
Device Size Text, specify0
Needle Gauge25 Gauge
Device Size Text, specify0
Needle Gauge25 Gauge
Device Size Text, specify0
Needle Gauge25 Gauge
Device Size Text, specify0
Needle Gauge25 Gauge
Device Size Text, specify0
Needle Gauge25 Gauge
Device Size Text, specify0
Needle Gauge25 Gauge
Device Size Text, specify0
Needle Gauge25 Gauge
Device Size Text, specify0
Needle Gauge25 Gauge
Device Size Text, specify0
Needle Gauge25 Gauge
Device Size Text, specify0
Needle Gauge25 Gauge
Device Size Text, specify0
Needle Gauge25 Gauge
Device Size Text, specify0
Needle Gauge25 Gauge
Device Size Text, specify0
Needle Gauge25 Gauge
Device Size Text, specify0
Needle Gauge25 Gauge
Device Size Text, specify0
Needle Gauge25 Gauge
Device Size Text, specify0
Needle Gauge25 Gauge
Device Size Text, specify0
Needle Gauge25 Gauge
Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *;

Device Identifiers

Device Issuing AgencyDevice ID
GS100855208005070 [Primary]
GS110855208005077 [Package]
Package: PACK_OR_INNER_PACK [5 Units]
In Commercial Distribution
GS190855208005073 [Package]
Package: CASE [999 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FCGBiopsy needle

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [BNX]

00855208005070FINE NEEDLE ASPIRATION NEEDLE
00855208005063FINE NEEDLE ASPIRATION NEEDLE
00855208005056FINE NEEDLE ASPIRATION NEEDLE
00855208005049FINE NEEDLE ASPIRATION SYSTEM
00855208005032FINE NEEDLE ASPIRATION SYSTEM
00855208005025FINE NEEDLE ASPIRATION SYSTEM
00855208005018FINE NEEDLE ASPIRATION SYSTEM
00855208005001FINE NEEDLE ASPIRATION SYSTEM
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