Disposable Falope-Ring® Band Applicator Kit

GUDID 00821925032989

Gyrus Acmi, Inc.

Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band Fallopian tube clip/band
Primary Device ID00821925032989
NIH Device Record Keyc708b6c5-fa48-4296-9882-c95a5fb57135
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable Falope-Ring® Band Applicator Kit
Version Model Number006889-901
Company DUNS007198742
Company NameGyrus Acmi, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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

Customer Support Contacts

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Phone1-888-524-7266
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Phone1-888-524-7266
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Phone1-888-524-7266
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Phone1-888-524-7266
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Phone1-888-524-7266
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Phone1-888-524-7266
Emailxxx@xxx.xxx
Phone1-888-524-7266
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Phone1-888-524-7266
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Phone1-888-524-7266
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Phone1-888-524-7266
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Phone1-888-524-7266
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Phone1-888-524-7266
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Phone1-888-524-7266
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Phone1-888-524-7266
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Phone1-888-524-7266
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Phone1-888-524-7266
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Phone1-888-524-7266
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Phone1-888-524-7266
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Phone1-888-524-7266
Emailxxx@xxx.xxx
Phone1-888-524-7266
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Phone1-888-524-7266
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Phone1-888-524-7266
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Device Identifiers

Device Issuing AgencyDevice ID
GS100821925000360 [Package]
Package: [8 Units]
In Commercial Distribution
GS100821925032989 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNHDevice, Occlusion, Tubal, Contraceptive

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-09-19

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00810008180501 - nCare2023-09-25 nCare, Sgl,Direct SDI,DICOM,Rcrdg
00810008180921 - nCare2023-09-25 nCare, Dual,ELA x 2,DICOM,Rcrdg
00810008180952 - nCare2023-09-25 nCare, SNGL,DRCT SDI,DICOM
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00810008180976 - nCare2023-09-25 nCare, SNGL, ELA, DICOM, RCRDG
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