HD1045

GUDID 30845854035966

10MM, 45 DEGREE HD AUTOCLAVABLE CARTRIDGE SCOPE

Conmed Corporation

Rigid optical laparoscope
Primary Device ID30845854035966
NIH Device Record Keyc2480ad0-6bf8-4e31-980e-3308a0880734
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberHD1045
Catalog NumberHD1045
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

Angle45 degree
Outer Diameter10 Millimeter
Angle45 degree
Outer Diameter10 Millimeter
Angle45 degree
Outer Diameter10 Millimeter
Angle45 degree
Outer Diameter10 Millimeter
Angle45 degree
Outer Diameter10 Millimeter
Angle45 degree
Outer Diameter10 Millimeter
Angle45 degree
Outer Diameter10 Millimeter
Angle45 degree
Outer Diameter10 Millimeter

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
GS120845854035969 [Primary]
GS130845854035966 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, general & plastic surgery

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[30845854035966]

Moist Heat or Steam Sterilization


[30845854035966]

Moist Heat or Steam Sterilization


[30845854035966]

Moist Heat or Steam Sterilization


[30845854035966]

Moist Heat or Steam Sterilization


[30845854035966]

Moist Heat or Steam Sterilization


[30845854035966]

Moist Heat or Steam Sterilization


[30845854035966]

Moist Heat or Steam Sterilization


[30845854035966]

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

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
20653405990144 - BioBrace2024-09-30 BioBrace® Reinforced Implant, 40 x 60 mm
20653405990151 - BioBrace2024-09-30 BioBrace® Reinforced Implant, Foot & Ankle, 40 x 60 mm

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