FDA.reportPublic FDA data

Gyrus ACMI

Primary DI
00821925030862
Brand
Gyrus ACMI
Company
Gyrus ACMI, LLC
Model
003991-501
Device description
Collection Bottle Caps
Published
2017-05-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
HHISYSTEM, ABORTION, VACUUM
HHKCurette, Suction, Endometrial (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HHISystem, Abortion, VacuumObstetrics/Gynecology2
HHKCurette, Suction, Endometrial (And Accessories)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171440000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171440000Berkeley VC-10 Vacuum Curettage SystemGyrus Acmi2017-09-29HHI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925030862PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925030862008219250308628219250308620821925030862

GMDN Terms#

Term, Definition table
TermDefinition
Abortion suction system collection bottleA component of an abortion (uterine) suction system designed to function as a trap to collect the products of conception from the uterus [the termination of early pregnancies (up to 12 weeks), the treatment of incomplete spontaneous abortions, the removal of retained afterbirth, menstrual regulation, or biopsy]. It is typically cylindrical in shape and connected to a wide bore tubing through which the removed material is suctioned. It may have an integrated filter made of woven textile that acts as a sieve and trap (blood passes through whilst solids are retained). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
007198742
Device count
1
Lot or batch
true
Manufacturing date on label
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
00860011927662Monarch Medical ProductsBioteque Taiwan Ltd.HHK2026-07-24
04719894436487LTL MedicalBioteque Taiwan Ltd.HHK2026-07-24
04719894436494LTL MedicalBioteque Taiwan Ltd.HHK2026-07-24
04719894436500LTL MedicalBioteque Taiwan Ltd.HHK2026-07-24
06974500612718Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612725Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612732Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612749Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612756Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612763Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612770Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612787Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612794Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612824Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612831Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612848Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612855Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612862Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612879Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612886Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612893Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612909Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500613333Flexible Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500613340Flexible Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500613357Flexible Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500613364Flexible Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500613371Flexible Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
00810142352338Bioteque America, Inc.Bioteque America, Inc.HHK2025-05-08
00810142352369Bioteque America, Inc.Bioteque America, Inc.HHK2025-05-08
04719894432335BiotequeBioteque Taiwan Ltd.HHK2024-12-06