Wire Electrode Needle Set Male

GUDID 20627825000509

Laborie Medical Technologies Canada ULC

Electromyographic needle electrode, single-use
Primary Device ID20627825000509
NIH Device Record Key6b1dc3ec-75f3-4b21-bfe6-1c40538dd3c7
Commercial Distribution StatusIn Commercial Distribution
Brand NameWire Electrode Needle Set Male
Version Model Number1512A-F
Company DUNS203383526
Company NameLaborie Medical Technologies Canada ULC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
GS100627825000505 [Primary]
GS110627825000502 [Package]
Contains: 00627825000505
Package: [40 Units]
In Commercial Distribution
GS120627825000509 [Package]
Contains: 10627825000502
Package: [560 Units]
In Commercial Distribution

FDA Product Code

FENDEVICE, CYSTOMETRIC, HYDRAULIC

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[20627825000509]

Ethylene Oxide


[20627825000509]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-06-11
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.