FDA.reportPublic FDA data

Gyrus ACMI

Primary DI
00821925028913
Brand
Gyrus ACMI
Company
Gyrus ACMI, LLC
Model
000948-501
Device description
Single Incision Inner Tube Assembly
Published
2024-07-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
KNHLaparoscopic Contraceptive Tubal Occlusion Device

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
00821925028913PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925028913008219250289138219250289130821925028913

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00821925019157VOCOM1430002015-10-24
00821925019164GYRUS ACMI, INC1430012015-10-24
00821925019171GYRUS ACMI, INC1430022015-10-24
00821925019225GYRUS ACMI, INC1430062015-10-24
00821925019232GYRUS ACMI, INC1430072015-10-24
00821925019249GYRUS ACMI, INC1430082015-10-24
00821925019300GYRUS ACMI, INC1430032015-10-24
00821925019317GYRUS ACMI, INC1430042015-10-24
00821925019324GYRUS ACMI, INC1430052015-10-24
00821925012738EVONOS GMBH & Co. Kg1300152018-09-04
00821925012783EVONOS1300202018-09-06
00821925012790EVONOS130021-ENT2018-09-06
00821925012806EVONOS1300222018-09-06
00821925012813EVONOS1300232018-09-06
00821925012820EVONOS1300242018-09-06
00821925012837Gyrus ACMI130025-ENT2018-09-06
00821925012929EVONOS1300382018-09-06
00821925013001EVONOS1302012018-09-10
00821925013018EVONOS1302022018-09-10
00821925013025EVONOS1302032018-09-10

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
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
00821925028852FALOPE RING Gyrus ACMI, LLCKNH2016-10-07
00861523000102Hulka ClipsRICHARD WOLF MEDICAL INSTRUMENTS CORP.KNH2014-11-11
05055515602121Filshie® ClipsFEMCARE LIMITEDKNH2014-09-25
05055515602138Filshie® Clip Applicator, 5mm SIFEMCARE LIMITEDKNH2014-09-25