Silicone Hubless Endo Drain Kit with Bendable Trocar

GUDID 04711182606541

FORTUNE MEDICAL INSTRUMENT CORP.

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Primary Device ID04711182606541
NIH Device Record Key6bfb4e8a-8109-4022-a461-80a89e1f7598
Commercial Distribution StatusIn Commercial Distribution
Brand NameSilicone Hubless Endo Drain Kit with Bendable Trocar
Version Model Number2015-9710B
Company DUNS656763489
Company NameFORTUNE MEDICAL INSTRUMENT CORP.
Device Count10
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104711182606541 [Unit of Use]
GS114711182606548 [Primary]

FDA Product Code

GCDConnector, Catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-01-17
Device Publish Date2022-01-07

On-Brand Devices [Silicone Hubless Endo Drain Kit with Bendable Trocar]

047111826068002015-9721B
047111826065962015-9719B
047111826065892015-9715B
047111826065412015-9710B

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