3D Laparoscope

GUDID 06973031299344

Guangdong Optomedic Technologies, Inc.

Rigid optical laparoscope
Primary Device ID06973031299344
NIH Device Record Keyc48b3564-7ec5-471a-bc6a-da4cfbe919ce
Commercial Distribution StatusIn Commercial Distribution
Brand Name3D Laparoscope
Version Model Number21033SA
Company DUNS544527790
Company NameGuangdong Optomedic Technologies, Inc.
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106973031299344 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06973031299344]

Moist Heat or Steam Sterilization


[06973031299344]

Moist Heat or Steam Sterilization


[06973031299344]

Moist Heat or Steam Sterilization


[06973031299344]

Moist Heat or Steam Sterilization


[06973031299344]

Moist Heat or Steam Sterilization


[06973031299344]

Moist Heat or Steam Sterilization


[06973031299344]

Moist Heat or Steam Sterilization


[06973031299344]

Moist Heat or Steam Sterilization


[06973031299344]

Moist Heat or Steam Sterilization


[06973031299344]

Moist Heat or Steam Sterilization


[06973031299344]

Moist Heat or Steam Sterilization


[06973031299344]

Moist Heat or Steam Sterilization


[06973031299344]

Moist Heat or Steam Sterilization


[06973031299344]

Moist Heat or Steam Sterilization


[06973031299344]

Moist Heat or Steam Sterilization


[06973031299344]

Moist Heat or Steam Sterilization


[06973031299344]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-23
Device Publish Date2024-08-15

On-Brand Devices [3D Laparoscope]

0697303129934421033SA
0697303129933721033SC

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