FDA.reportPublic FDA data

FALOPE RING

Primary DI
00821925028852
Brand
FALOPE RING
Company
Gyrus ACMI, LLC
Model
000875-901
Device description
FALOPE RING GUIDE & O-RING
Published
2016-10-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
KNHdevice, occlusion, tubal, contraceptive, laparoscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNHLaparoscopic Contraceptive Tubal Occlusion DeviceObstetrics/Gynecology3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P870076000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P870076000FALOPE RING BAND AND APPLICATOR SYSTEMSGyrus Acmi, Inc.1993-09-29KNH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925028852PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925028852008219250288528219250288520821925028852

GMDN Terms#

Term, Definition table
TermDefinition
Fallopian tube clip/bandAn implantable device applied externally to the fallopian tube(s) to constrict the tube and prevent the passage of ova. It is typically used during tubal ligation procedures and functions as a contraceptive device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
007198742
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00821925034433Gyrus ACMI1315002016-10-07
00821925002104USA Elite SystemEOS-HCF272024-11-21
00821925002074USA Elite SystemEOS-CFR-252024-07-25
00821925002470SlimlineGYA-52024-07-24
00821925002494SlimLineGYB-52024-07-24
00821925002562SlimLineGYS-52024-07-24
00821925002579GYRUS ACMI, INCGYS-7422024-07-24
00821925004634Gyrus ACMI2442024-07-23
00821925001152URO-GUIDE54960162015-10-24
00821925001169URO-GUIDE54960202015-10-24
00821925001480USA EliteCLO-232016-10-13
00821925001497USA EliteCLS-232016-10-13
00821925001602Elite 2 SystemE2RIS-CF272016-10-13
00821925001626Elite 2 SystemE2ROS-CF272016-10-13
00821925001633Elite 2 SystemE2RST-CF252016-10-13
00821925001657Elite 2 SystemE2RTO-CF252016-10-13
00821925001664Elite 2 SystemE2RTO-CF272016-10-13
00821925001671Elite 2 SystemE2RVO-CF252016-10-13
00821925001688Elite 2 SystemE2RVO-CF272016-10-13
00821925001695Elite 2 SystemE2TO-CF252016-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
25055515602248Filshie® Clips (Femcare)FEMCARE LIMITEDKNH2025-02-28
25055515602262Filshie® ClipsFEMCARE LIMITEDKNH2025-02-28
05055515602244Filshie® Clips (Femcare)FEMCARE LIMITEDKNH2025-02-28
00821925028869FALOPE-RINGGyrus ACMI, LLCKNH2024-07-12
00821925028913Gyrus ACMIGyrus ACMI, LLCKNH2024-07-12
15055515602265Filshie® ClipsFEMCARE LIMITEDKNH2023-05-15
05055515602268Filshie® ClipsFEMCARE LIMITEDKNH2023-05-15
15055515602326SterishotFEMCARE LIMITEDKNH2023-05-15
15055515602340Sterishot (Femcare) for MinilaparotomyFEMCARE LIMITEDKNH2023-05-15
00868029000391Head Coil (Receive Only)VIEWRAY INCORPORATEDKNH2022-05-06
15055515602371Sterishot II Elite KitFEMCARE LIMITEDKNH2021-01-14
15055515602234Filshie® Clips (Femcare)FEMCARE LIMITEDKNH2019-02-01
15055515602241Filshie® Clips (Femcare)FEMCARE LIMITEDKNH2019-02-01
15055515602272Filshie® Clip Applicator, Minilap (Femcare)FEMCARE LIMITEDKNH2019-02-01
15055515602289Filshie® Clip Applicator, 7.3mm SI (Femcare)FEMCARE LIMITEDKNH2019-02-01
15055515602296Filshie® Clip Applicator, 7mm DI (Femcare)FEMCARE LIMITEDKNH2019-02-01
15055515602302Filshie® Clip Applicator, 5mm SI (Femcare)FEMCARE LIMITEDKNH2019-02-01
15055515602333Sterishot II KitFEMCARE LIMITEDKNH2019-02-01
15055515602357Sterishot (Femcare) for MinilaparotomyFEMCARE LIMITEDKNH2019-02-01
25055515602194SterishotFEMCARE LIMITEDKNH2018-12-06
15055515602197Sterishot Kit for Minilaparotomy (CSI)FEMCARE LIMITEDKNH2018-12-06
05055515602114Filshie® ClipsFEMCARE LIMITEDKNH2017-06-22
25055515602187SterishotFEMCARE LIMITEDKNH2017-06-21
15055515602180Sterishot II Kit (CSI)FEMCARE LIMITEDKNH2017-06-21
00821925000186Gyrus ACMIGyrus ACMI, LLCKNH2017-05-08
15055515600759SterishotFEMCARE LIMITEDKNH2016-12-21
25055515600756SterishotFEMCARE LIMITEDKNH2016-12-21
00861523000102Hulka ClipsRICHARD WOLF MEDICAL INSTRUMENTS CORP.KNH2014-11-11
05055515602121Filshie® ClipsFEMCARE LIMITEDKNH2014-09-25
05055515602138Filshie® Clip Applicator, 5mm SIFEMCARE LIMITEDKNH2014-09-25