FDA.reportPublic FDA data

AROM-COT

Primary DI
H671AR1000
Brand
AROM-COT
Company
UTAH MEDICAL PRODUCTS, INC.
Model
Small
Catalog number
AR100
Device description
AROM-COT FINGERCOT W/ATTACHED HOOK
Published
2020-06-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HGEAmniotome

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGEAmniotomeObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H671AR1001PackageHIBCC100In Commercial Distribution
H671AR1000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Amniotome, single-useA surgical instrument used to cut/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 long and shaft-like, and terminates in a sharp hook or protected blade used to rupture the membrane. It is typically made of disposable plastic materials, and may be curved to follow the natural contours of the birthing canal into which it is inserted. Amniotic membrane rupture may also be performed using an amniotic perforator or forceps and/or a trocar. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-533-4984customer@utahmed.com

Regulatory Flags#

DUNS number
094651270
Device count
1
Premarket exempt
true
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
H671303TT0CMITender Touch Cup303TT2016-09-23
H671303TTL0CMITender Touch Cup303TTL2016-09-23
H671404TT0CMITender Touch Cup404TT2016-09-23
H67141828050UMBILI-CATHSingle-Lumen Polyurethane41828052016-09-23
H67141835050UMBILI-CATHSingle-Lumen Polyurethane41835052016-09-23
H67141850050UMBILI-CATHSingle-Lumen Polyurethane41850052016-09-23
H67141865050UMBILI-CATHSingle-Lumen Polyurethane41865052016-09-23
H67142828050UMBILI-CATHDual-Lumen Polyurethane42828052016-09-23
H67142835050UMBILI-CATHDual-Lumen Polyurethane42835052016-09-23
H67142850050UMBILI-CATHDual-Lumen Polyurethane42850052016-09-23
H67143850050UMBILI-CATHTriple-Lumen Polyurethane43850052016-09-23
H671444FC0CMIFlex Cup444FC2016-09-23
H671505TT0CMIUltra Cup505TT2016-09-23
H671505TTL0CMIUltra Cup505TTL2016-09-23
H671506TTL0CMIUltra Cup506TTL2016-09-23
H671600TT0CMISecure Cup600TT2016-09-23
H671606TT0CMISecure Cup606TT2016-09-23
H671IUP4000INTRANPlusIUP-4002016-09-23
H671IUP4500INTRANPlusIUP-4502016-09-23
H671IUP5000INTRANPlusIUP-5002016-09-23

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
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
09350902000174AmnicotGO MEDICAL INDUSTRIES PTY. LTD.HGE2016-09-24
09350902000211AmnicotGO MEDICAL INDUSTRIES PTY. LTD.HGE2016-09-24