Silicone Birth Vac Cup

GUDID 04711182604004

FORTUNE MEDICAL INSTRUMENT CORP.

Foetal vacuum extraction system cup, reusable
Primary Device ID04711182604004
NIH Device Record Key105ca7c6-fe44-4674-941b-d14cf83b3692
Commercial Distribution StatusIn Commercial Distribution
Brand NameSilicone Birth Vac Cup
Version Model Number1300-0050
Company DUNS656763489
Company NameFORTUNE MEDICAL INSTRUMENT CORP.
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 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
GS104711182604004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HDBExtractor, Vacuum, Fetal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-21
Device Publish Date2016-03-10

On-Brand Devices [Silicone Birth Vac Cup]

047111826040041300-0050
047109619300131300-0070
047109619300061300-0060

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