JustRight Sealer JR-SE20

GUDID 10865163000123

JustRight Sealer - single

JUSTRIGHT SURGICAL, LLC

Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use Endoscopic electrosurgical handpiece/electrode, bipolar, single-use
Primary Device ID10865163000123
NIH Device Record Key6d165e78-f06d-4e62-9557-8c8ea9fcde1b
Commercial Distribution StatusIn Commercial Distribution
Brand NameJustRight Sealer
Version Model NumberJR-SE20
Catalog NumberJR-SE20
Company DUNS025214641
Company NameJUSTRIGHT SURGICAL, LLC
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 Datefalse
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(866)683-1743
Emailcustomersupport@justrightsurgical.com
Phone+1(866)683-1743
Emailcustomersupport@justrightsurgical.com
Phone+1(866)683-1743
Emailcustomersupport@justrightsurgical.com
Phone+1(866)683-1743
Emailcustomersupport@justrightsurgical.com
Phone+1(866)683-1743
Emailcustomersupport@justrightsurgical.com
Phone+1(866)683-1743
Emailcustomersupport@justrightsurgical.com
Phone+1(866)683-1743
Emailcustomersupport@justrightsurgical.com
Phone+1(866)683-1743
Emailcustomersupport@justrightsurgical.com
Phone+1(866)683-1743
Emailcustomersupport@justrightsurgical.com
Phone+1(866)683-1743
Emailcustomersupport@justrightsurgical.com
Phone+1(866)683-1743
Emailcustomersupport@justrightsurgical.com
Phone+1(866)683-1743
Emailcustomersupport@justrightsurgical.com
Phone+1(866)683-1743
Emailcustomersupport@justrightsurgical.com
Phone+1(866)683-1743
Emailcustomersupport@justrightsurgical.com
Phone+1(866)683-1743
Emailcustomersupport@justrightsurgical.com
Phone+1(866)683-1743
Emailcustomersupport@justrightsurgical.com
Phone+1(866)683-1743
Emailcustomersupport@justrightsurgical.com
Phone+1(866)683-1743
Emailcustomersupport@justrightsurgical.com
Phone+1(866)683-1743
Emailcustomersupport@justrightsurgical.com

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Device Identifiers

Device Issuing AgencyDevice ID
GS100865163000126 [Primary]
GS110865163000123 [Package]
Contains: 00865163000126
Package: Case [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10865163000123]

Ethylene Oxide

[10865163000123]

Ethylene Oxide

[10865163000123]

Ethylene Oxide

[10865163000123]

Ethylene Oxide

[10865163000123]

Ethylene Oxide

[10865163000123]

Ethylene Oxide

[10865163000123]

Ethylene Oxide

[10865163000123]

Ethylene Oxide

[10865163000123]

Ethylene Oxide

[10865163000123]

Ethylene Oxide

[10865163000123]

Ethylene Oxide

[10865163000123]

Ethylene Oxide

[10865163000123]

Ethylene Oxide

[10865163000123]

Ethylene Oxide

[10865163000123]

Ethylene Oxide

[10865163000123]

Ethylene Oxide

[10865163000123]

Ethylene Oxide

[10865163000123]

Ethylene Oxide

[10865163000123]

Ethylene Oxide

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-04-23
Device Publish Date2015-08-10

Devices Manufactured by JUSTRIGHT SURGICAL, LLC

00850346007085 - CoolSeal™ Mini2021-05-19 Maryland Laparoscopic Sealer
00850346007023 - CoolSeal™ Generator2020-10-21 Electrosurgical Generator
10850346007037 - CoolSeal™ Trinity2020-10-21 Maryland Laparoscopic Sealer/Divider/Dissector, 30 cm
10850346007044 - CoolSeal™ Trinity2020-10-21 Maryland Laparoscopic Sealer/Divider/Dissector, 37 cm
10850346007068 - CoolSeal™ Trinity2020-10-21 Maryland Laparoscopic Sealer/Divider/Dissector, 44 cm
10850346007099 - CoolSeal™ Mini2020-10-21 Maryland Laparoscopic Sealer
10865163000109 - JustRight 5mm Stapler2019-05-07 JustRight 5mm Stapler-single
10865163000116 - JustRight5mm Reload2019-05-07 JustRight 5mm Reload - single
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