FDA.reportPublic FDA data

Vacurette

Primary DI
00821925000025
Brand
Vacurette
Company
Gyrus ACMI, LLC
Model
003696
Device description
Adapter, 14 mm Vacurette
Published
2024-07-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925000025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925000025008219250000258219250000250821925000025

GMDN Terms#

Term, Definition table
TermDefinition
Endometrial biopsy curetteA hand-held, surgical instrument used to for the removal of small amounts of endometrial secretions and/or tissue from the uterus for biopsy purposes. It is typically made of high-grade stainless steel and is available in a variety of designs: 1) a long, thin, instrument with very small spoon-like scoop terminating at either end and a centrally placed handle; 2) a long, thin tubular device with a serrated opening at the distal end and a connection to a suction device or a syringe at the proximal end; or 3) a single-ended device with a scraper at the distal end. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
007198742
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00821925034013Expandacell708907302018-09-13
00821925034020Gyrus ACMI708909072018-09-13
00821925034037Gyrus ACMI708909082018-09-13
00821925034532Gyrus ACMI8909112018-09-13
00821925037069Rhino Rocket708907292018-09-13
00821925037076Rhino Rocket708907312018-09-13
00821925037090Gyrus ACMI708907332018-09-13
00821925037106SlimLine708907342018-09-13
00821925037113Gyrus ACMI708907352018-09-13
00821925037120Gyrus ACMI708907372018-09-13
00821925037137Gyrus ACMI708907382018-09-13
00821925037144Gyrus ACMI708907392018-09-13
00821925037151Gyrus ACMI708907402018-09-13
00821925037168Gyrus ACMI708907412018-09-13
00821925037175Gyrus ACMI708907422018-09-13
00821925037182Gyrus ACMI708907432018-09-13
00821925037199Gyrus ACMI708907502018-09-13
00821925037205Gyrus ACMI708907512018-09-13
00821925037212Gyrus ACMI708907522018-09-13
00821925037229Gyrus ACMI708907532018-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00821925029231DISPOSA-TOPGyrus ACMI, LLCHHK2024-07-25
00821925000926Gyrus ACMIGyrus ACMI, LLCHHK2024-07-24
04719894433363BiotequeBioteque Taiwan Ltd.HHK2024-04-08
04719894432311BiotequeBioteque Taiwan Ltd.HHK2024-04-08