injeTAK Adjustable Tip Needle 70cm

GUDID 20627825000028

Laborie Medical Technologies Canada ULC

General-purpose endoscopic needle, single-use
Primary Device ID20627825000028
NIH Device Record Keya3ae2410-82ab-41e9-8bb7-569dbb0ba6a7
Commercial Distribution StatusIn Commercial Distribution
Brand NameinjeTAK Adjustable Tip Needle 70cm
Version Model NumberDIS201
Company DUNS203383526
Company NameLaborie Medical Technologies Canada ULC
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 Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100627825000024 [Primary]
GS110627825000021 [Package]
Contains: 00627825000024
Package: [2 Units]
In Commercial Distribution
GS120627825000028 [Package]
Contains: 10627825000021
Package: [50 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FBKendoscopic injection needle, gastroenterology-urology

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[20627825000028]

Ethylene Oxide


[20627825000028]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-21

Devices Manufactured by Laborie Medical Technologies Canada ULC

30627825007024 - Extension Set 22022-07-04
20627825007294 - Extension Line, 60 cm2022-07-04
20627825007317 - Extension Line, 1500mm2022-07-04
20627825007324 - Extension Line, 15cm2022-07-04
20627825007348 - Extension Line, 150cm Blue2022-07-04
30627825007352 - Extension Line, 150cm Yellow2022-07-04
20627825007034 - Extension Set 32022-07-04
30627825007307 - Extension Line, 90 cm2022-07-04

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