superDimension AKI00101-01

GUDID 20884521200477

Aspirating 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
Primary Device ID20884521200477
NIH Device Record Key142e046d-eccc-474e-bdff-66b7c59f4116
Commercial Distribution StatusIn Commercial Distribution
Brand NamesuperDimension
Version Model NumberAKI00101-01
Catalog NumberAKI00101-01
Company DUNS058614483
Company NameCovidien LP
Device Count1
DM Exempttrue
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 Latextrue
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

Device Dimensions

Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;

Device Identifiers

Device Issuing AgencyDevice ID
GS110884521200470 [Primary]
GS110884521200470 [Primary]
GS110884521200470 [Primary]
GS110884521200470 [Primary]
GS110884521200470 [Primary]
GS110884521200470 [Primary]
GS110884521200470 [Primary]
GS110884521200470 [Primary]
GS110884521200470 [Primary]
GS110884521200470 [Primary]
GS110884521200470 [Primary]
GS110884521200470 [Primary]
GS110884521200470 [Primary]
GS110884521200470 [Primary]
GS120884521200477 [Package]
Contains: 10884521200470
Package: CASE [5 Units]
In Commercial Distribution
GS120884521200477 [Package]
Contains: 10884521200470
Package: CASE [5 Units]
In Commercial Distribution
GS120884521200477 [Package]
Contains: 10884521200470
Package: CASE [5 Units]
In Commercial Distribution
GS120884521200477 [Package]
Contains: 10884521200470
Package: CASE [5 Units]
In Commercial Distribution
GS120884521200477 [Package]
Contains: 10884521200470
Package: CASE [5 Units]
In Commercial Distribution
GS120884521200477 [Package]
Contains: 10884521200470
Package: CASE [5 Units]
In Commercial Distribution
GS120884521200477 [Package]
Contains: 10884521200470
Package: CASE [5 Units]
In Commercial Distribution
GS120884521200477 [Package]
Contains: 10884521200470
Package: CASE [5 Units]
In Commercial Distribution
GS120884521200477 [Package]
Contains: 10884521200470
Package: CASE [5 Units]
In Commercial Distribution
GS120884521200477 [Package]
Contains: 10884521200470
Package: CASE [5 Units]
In Commercial Distribution
GS120884521200477 [Package]
Contains: 10884521200470
Package: CASE [5 Units]
In Commercial Distribution
GS120884521200477 [Package]
Contains: 10884521200470
Package: CASE [5 Units]
In Commercial Distribution
GS120884521200477 [Package]
Contains: 10884521200470
Package: CASE [5 Units]
In Commercial Distribution
GS120884521200477 [Package]
Contains: 10884521200470
Package: CASE [5 Units]
In Commercial Distribution

FDA Product Code

GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-09-16
Device Publish Date2018-08-29

On-Brand Devices [superDimension]

20884521200514Pre-Marked Biopsy Forceps
20884521200484Biopsy Forceps
20884521198804Fiducial Marker;3-Band
20884521198781Fiducial Marker;Coil
20884521198774Fiducial Marker;Coil
20884521197708Fiducial Marker;Coil
10884521198722Patient Sensor Patch
10884521785861superDimension Planning Station
10884521806153navigation system console
10884521582835Planning Station
10884521545588Planning Station
10884521200364iLogic inReach;Planning Laptop
20884521200477Aspirating Needle

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