FemCath 03207

GUDID 00859500005080

FemCath CBC-150 with VariLock and FemVue, 1 Pack

FEMASYS INC.

Salpingographic catheter
Primary Device ID00859500005080
NIH Device Record Key9c60260b-3853-4249-8df0-ffa00d5fefdd
Commercial Distribution StatusIn Commercial Distribution
Brand NameFemCath
Version Model NumberCBC-150
Catalog Number03207
Company DUNS147590330
Company NameFEMASYS 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100859500005080 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LKFCannula, Manipulator/Injector, Uterine

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-14
Device Publish Date2023-06-06

On-Brand Devices [FemCath]

00859500005035FemCath, Cornual Balloon Catheter, CBC-100 with StopLock, 1 Pack (tray)
00859500005080FemCath CBC-150 with VariLock and FemVue, 1 Pack
00859500005042CBC-1501, Bulk, Sterile

Trademark Results [FemCath]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FEMCATH
FEMCATH
97089476 not registered Live/Pending
Femasys Inc.
2021-10-23

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