Medisystems Button Hole Needle Set

GUDID 10842289100715

MEDISYSTEMS CORPORATION

Haemodialysis needle
Primary Device ID10842289100715
NIH Device Record Keyf8d3a168-c60d-481e-9ec2-99aaa18d93f7
Commercial Distribution Discontinuation2020-06-29
Commercial Distribution StatusNot in Commercial Distribution
Brand NameMedisystems Button Hole Needle Set
Version Model NumberBH-7616
Company DUNS061310132
Company NameMEDISYSTEMS CORPORATION
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-866-697-8243
EmailInfo@nxstage.com

Device Dimensions

Needle Gauge16 Gauge
Needle Gauge16 Gauge

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100842289100718 [Primary]
GS110842289100715 [Package]
Contains: 00842289100718
Package: [250 Units]
Discontinued: 2020-06-29
Not in Commercial Distribution

FDA Product Code

FIENeedle, Fistula

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-06-30
Device Publish Date2016-09-16

On-Brand Devices [Medisystems Button Hole Needle Set]

10842289100715BH-7616
10842289100708BH-7615
10842289100685BH-7606
10842289100661BH-7605
10842289100654BH-7037
10842289100647BH-7036
10842289100630BH-7035
10842289100623BH-7016
10842289100616BH-7015
10842289100609BH-7014
10842289100593BH-7005
10842289100586BH-7007
10842289100555BH-7004
10842289100548BH-7006

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