Amnicot

Primary DI
09350902000174
Brand
Amnicot
Company
GO MEDICAL INDUSTRIES PTY. LTD.
Model
Amnicot English
Catalog number
ACD01-E
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HGEAmniotome

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGEAmniotomeObstetrics/Gynecology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K850758000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K850758000AMNIGLOVE & AMNICOTGo Medical Industries Pty. , Ltd.1985-04-15HGE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
9350902000181PackageGS1100In Commercial Distribution
9350902000198PackageGS12600In Commercial Distribution
9350902000204PackageGS15200In Commercial Distribution
09350902000174PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
9350902000181093509020001819350902000181
9350902000198093509020001989350902000198
9350902000204093509020002049350902000204
09350902000174093509020001749350902000174

GMDN Terms#

Term, Definition table
TermDefinition
Amniotic membrane perforator, single-useA surgical instrument used to rupture the amniotic membrane (i.e., the amnion - the thin, tough membrane that lines the chorion and contains the foetus and the amniotic fluid) to assist in childbirth, without causing injury to the mother or foetus. It is typically long and shaft-like, and terminates in a rounded nose with a sharp hook. It is made of plastic materials, and may be straight or curved to follow the natural contours of the birthing canal into which it is inserted. Amniotic membrane rupture may also be performed using an amniotome or forceps and/or a trocar. This is a single-use device.

Regulatory Flags#

DUNS number
757634266
Device count
1
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09350902000396Flow Control TubingFCT 10mL/5minFCT10-5m2016-09-24
09350902000426Flow Control TubingFCT 10mL/15minFCT10-15m2016-09-24
09350902000457Flow Control TubingFCT 10mL/30minFCT10-30m2016-09-24
09350902000488Flow Control TubingFCT 10mL/60minFCT10-60m2016-09-24
09350902000518Flow Control TubingFCT 10mL/2hFCT10-2h2016-09-24
09350902000549Flow Control TubingFCT 10mL/4hFCT10-4h2016-09-24
09350902000570Flow Control TubingFCT 10mL/6hFCT10-6h2016-09-24
09350902000600Flow Control TubingFCT 10mL/8hFCT10-8h2016-09-24
09350902000631Flow Control TubingFCT 10mL/12hFCT10-12h2016-09-24
09350902000662Flow Control TubingFCT 10mL/24hFCT10-24h2016-09-24
09350902000693Flow Control TubingFCT 10mL/48hFCT10-48h2016-09-24
09350902000723Flow Control TubingFCT 10mL/72hFCT10-72h2016-09-24
09350902000754Flow Control TubingFCT 30mL/5minFCT30-5m2017-05-16
09350902000785Flow Control TubingFCT 30mL/15minFCT30-15m2017-05-16
09350902000815Flow Control TubingFCT 30mL/30minFCT30-30m2017-05-16
09350902000846Flow Control TubingFCT 30mL/60minFCT30-60m2017-05-16
09350902000877Flow Control TubingFCT 30mL/2hFCT30-2h2017-05-16
09350902000907Flow Control TubingFCT 30mL/4hFCT30-4h2017-05-16
09350902000938Flow Control TubingFCT 30mL/6hFCT30-6h2017-05-16
09350902000969Flow Control TubingFCT 30mL/8hFCT30-8h2017-05-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04049047043737GimmiGimmi GmbHHGE2025-05-13
M803020301MedGyn Disposable Amnio HookMEDGYN PRODUCTS, INC.HGE2024-04-30
00849233010505BUSSE HOSPITAL DISPOSABLESROBERT BUSSE & CO., INC.HGE2023-08-09
10849233010502BUSSE HOSPITAL DISPOSABLESROBERT BUSSE & CO., INC.HGE2023-08-09
07898506815289QuinelatoSchobell Industrial LtdaHGE2023-07-05
00840113231485Amnihook Amniotic Membrane PerforatorASPEN SURGICAL PRODUCTS, INC.HGE2023-02-27
00888937014761mityhookCoopersurgical, Inc.HGE2022-12-01
00749756166362DeRoyalDEROYAL INDUSTRIES, INC.HGE2021-07-12
00749756166379DeRoyalDEROYAL INDUSTRIES, INC.HGE2021-07-12
50749756166367DeRoyalDEROYAL INDUSTRIES, INC.HGE2021-07-12
50749756166374DeRoyalDEROYAL INDUSTRIES, INC.HGE2021-07-12
10767056096018Mabis DMID-M-S HOLDINGS, INC.HGE2021-05-19
00827002343122ObstiHookCOOK INCORPORATEDHGE2020-10-02
10827002343129ObstiHookCOOK INCORPORATEDHGE2020-10-02
H671AR1000AROM-COTUTAH MEDICAL PRODUCTS, INC.HGE2020-06-04
H671AR2000AROM-COTUTAH MEDICAL PRODUCTS, INC.HGE2020-06-04
04038653155002AESCULAPAesculap AGHGE2020-05-08
10381780506706Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHGE2018-09-12
H8343022600Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHGE2018-09-12
09350902000211AmnicotGO MEDICAL INDUSTRIES PTY. LTD.HGE2016-09-24