Poly Surgiclip 133649

GUDID 20884521133676

Clip Applier with Polysorb Clips

Covidien LP

Ligation clip, metallic
Primary Device ID20884521133676
NIH Device Record Key1fa7c8b1-daa4-4e3c-ad3c-edf4826c61a0
Commercial Distribution StatusIn Commercial Distribution
Brand NamePoly Surgiclip
Version Model Number133649
Catalog Number133649
Company DUNS058614483
Company NameCovidien LP
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS110884521133679 [Primary]
GS120884521133676 [Package]
Contains: 10884521133679
Package: CASE [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FZPCLIP, IMPLANTABLE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-02-05
Device Publish Date2015-08-28

Devices Manufactured by Covidien LP

10884521581876 - Barrx2024-11-15 360 Express RFA Balloon Catheter
10884521581753 - Barrx2024-11-12 Channel RFA Endoscopic Catheter Esophageal TTS, 120 Applications
10884521581821 - Barrx2024-11-12 90 RFA Focal Catheter Chang Cap, 80 Applications
10884521581838 - Barrx2024-11-12 Ultra Long RFA Focal Catheter 80 Applications
10884521581845 - Barrx2024-11-12 60 RFA Focal Catheter 80 Applications
20884521811130 - Ritus2024-10-29 Peritoneal Dialysis Accessory Beta-Cap Adapter
20884521811208 - Ritus2024-10-29 Peritoneal Dialysis Accessory Blunt Tunneling Stylet
10884521811225 - Ritus2024-10-29 Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter

Trademark Results [Poly Surgiclip]

Mark Image

Registration | Serial
Company
Trademark
Application Date
POLY SURGICLIP
POLY SURGICLIP
73428397 1302472 Live/Registered
United States Surgical Corporation
1983-06-01

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