FDA.report

Marina Medical

Primary DI
00840306826191
Brand
Marina Medical
Company
MARINA MEDICAL INSTRUMENTS, INC.
Model
AMI-1151
Catalog number
AMI-1151
Device description
4.5 Uterine Manipulator/Injector, 10cc Balloon, Sterile/ Disposable, 12/BX-ACTIVE
Published
2024-05-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GEIElectrosurgical, cutting & coagulation & accessories
LKFCannula, manipulator/injector, uterine

Product Code Classifications

CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2
LKFCannula, Manipulator/Injector, UterineObstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840306826184PrimaryGS10
00840306826191Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840306826184008403068261848403068261840840306826184
00840306826191008403068261918403068261910840306826191

GMDN Terms

TermDefinition
Uterine manipulator, single-useA sterile, hand-held manual surgical instrument designed to atraumatically mechanically manipulate the position of the uterus during a gynaecological intervention (e.g., laparoscopy) to enable uterine control and improved visibility of the pelvic anatomy, as well as for chromotubation. The device typically consists of a long shaft with an inflatable balloon at the distal end which is transcervically placed inside the uterus and inflated, via a connected syringe (sometimes included), with sterile saline or air; once inflated, the operator can manipulate the uterus. Deflation is a reverse of the inflation process. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(954)924-4419enrico@marinamedical.com
+1(954)924-4418enrico@marinamedical.com

Regulatory Flags

DUNS number
011442279
Device count
12
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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