Single Use Repositionable Clip

GUDID 14953170345149

OLYMPUS MEDICAL SYSTEMS CORP.

Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic Ligation clip, metallic
Primary Device ID14953170345149
NIH Device Record Key4e1441ed-29bc-467a-b4cf-031969ea199c
Commercial Distribution StatusIn Commercial Distribution
Brand NameSingle Use Repositionable Clip
Version Model NumberHX-202LR
Company DUNS711789789
Company NameOLYMPUS MEDICAL SYSTEMS CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS104953170345142 [Primary]
GS114953170345149 [Package]
Contains: 04953170345142
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PKLHemostatic metal clip for the GI tract

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

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

On-Brand Devices [Single Use Repositionable Clip]

14953170385947HX-202UR
14953170385930HX-202UR
14953170385923HX-202LR
14953170385916HX-202LR
14953170345200HX-202UR
14953170345187Single Use Repositionable Clip
14953170345163HX-202LR
14953170345149HX-202LR

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