Dynarex Corporation

GUDID 36970754494866

GCMEDICA ENTERPRISE LTD. (WUXI)

Suction system canister liner
Primary Device ID36970754494866
NIH Device Record Keyf83323a0-510d-4fbc-ade4-82516457e88b
Commercial Distribution StatusIn Commercial Distribution
Brand NameDynarex Corporation
Version Model NumberGC1957R08
Company DUNS527142751
Company NameGCMEDICA ENTERPRISE LTD. (WUXI)
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS116970754494862 [Primary]
GS136970754494866 [Package]
Contains: 16970754494862
Package: [10 Units]
In Commercial Distribution

FDA Product Code

GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-02-13
Device Publish Date2023-02-04

Devices Manufactured by GCMEDICA ENTERPRISE LTD. (WUXI)

16970754496156 - Orthopaedic Suction Set2023-09-18 Sterile, single use, easyflow filtered suction system, for orthopaedic surgery.
36970754494866 - Dynarex Corporation2023-02-13
36970754494866 - Dynarex Corporation2023-02-13

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