HD5545

GUDID 30845854027169

5.5MM 45 DEGREE HD AUTOCLAVABLE CARTRIDGE SCOPE

Conmed Corporation

Rigid optical laparoscope
Primary Device ID30845854027169
NIH Device Record Key55d877b3-5212-4710-998a-96e8cf8754bd
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberHD5545
Catalog NumberHD5545
Company DUNS071595540
Company NameConmed 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 Usefalse
Lot Batchfalse
Serial Numbertrue
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(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM

Device Dimensions

Outer Diameter5.5 Millimeter
Angle45 degree
Outer Diameter5.5 Millimeter
Angle45 degree
Outer Diameter5.5 Millimeter
Angle45 degree
Outer Diameter5.5 Millimeter
Angle45 degree
Outer Diameter5.5 Millimeter
Angle45 degree
Outer Diameter5.5 Millimeter
Angle45 degree
Outer Diameter5.5 Millimeter
Angle45 degree
Outer Diameter5.5 Millimeter
Angle45 degree

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP DRY

Device Identifiers

Device Issuing AgencyDevice ID
GS120845854027162 [Primary]
GS130845854027169 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, general & plastic surgery

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[30845854027169]

Moist Heat or Steam Sterilization


[30845854027169]

Moist Heat or Steam Sterilization


[30845854027169]

Moist Heat or Steam Sterilization


[30845854027169]

Moist Heat or Steam Sterilization


[30845854027169]

Moist Heat or Steam Sterilization


[30845854027169]

Moist Heat or Steam Sterilization


[30845854027169]

Moist Heat or Steam Sterilization


[30845854027169]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

Devices Manufactured by Conmed Corporation

10653405008125 - NA2024-12-04 CONMED REUSABLE DISPERSIVE ELECTRODE
10653405008132 - NA2024-12-04 CONMED REUSABLE PEDIATRIC DISPERSIVE ELECTRODE
30653405987585 - PlumeSafe® X5™2024-10-22 PlumeSafe® X5™ Smoke Evacuation Unit, 220V-240V 50/60 Hz
30653405987592 - PlumeSafe® X5™2024-10-22 PlumeSafe® X5™ Smoke Evacuation Unit with PlumeSafe® X5™ Smoke Evacuator Filter, 220V-240V 50/60 Hz
30653405987608 - PlumeSafe® X5™2024-10-22 PlumeSafe® X5™ Smoke Evacuation Unit, 220V-240V 50/60 Hz
30653405990141 - PlumeSafe® X5™2024-10-22 PlumeSafe® X5™ Smoke Evacuation Unit with PlumeSafe® X5™ Smoke Evacuator Filter, 220V-240V 50/60 Hz
20653405990120 - BioBrace2024-09-30 BioBrace® Reinforced Implant, 23 x 25 mm
20653405990137 - BioBrace2024-09-30 BioBrace® Reinforced Implant, 35 x 25 mm

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