FDA.reportPublic FDA data

Uterine ElevatOR Pro with OccludOR Balloon

Primary DI
09349967003343
Brand
Uterine ElevatOR Pro with OccludOR Balloon
Company
THE O R COMPANY PTY LTD
Model
UE-OBPRO-35
Published
2019-03-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LKFCannula, Manipulator/Injector, Uterine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LKFCannula, Manipulator/Injector, UterineObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09349967003336PackageGS18In Commercial Distribution
09349967003343PackageGS16In Commercial Distribution
09349967003329PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09349967003336093499670033369349967003336
09349967003343093499670033439349967003343
09349967003329093499670033299349967003329

GMDN Terms#

Term, Definition table
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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter32Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
744346235
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
19349967004965Uterine ElevatOR PRO with OccludOR Balloon™UE-OBPRO-35NTUE-OBPRO-35NT2023-05-26
19349967004972Uterine ElevatOR PRO with OccludOR Balloon™UE-OBPRO-37NTUE-OBPRO-37NT2023-05-26
19349967004989Uterine ElevatOR PRO with OccludOR Balloon™UE-OBPRO-40NTUE-OBPRO-40NT2023-05-26
19349967005016Uterine ElevatOR PRO with OccludOR Balloon™UE-OBPRO-32NTUE-OBPRO-32NT2023-05-26
19349967005061Uterine ElevatOR PRO with Long Handle™UE-LHPRO-32NTUE-LHPRO-32NT2023-05-26
19349967005078Uterine ElevatOR PRO with Long Handle™UE-LHPRO-35NTUE-LHPRO-35NT2023-05-26
19349967005085Uterine ElevatOR PRO with Long Handle™UE-LHPRO-37NTUE-LHPRO-37NT2023-05-26
19349967005092Uterine ElevatOR PRO with Long Handle™UE-LHPRO-40NTUE-LHPRO-40NT2023-05-26
19349967005108Uterine PositionOR PRO™UE-PLH-NTUE-PLH-NT2023-05-26
29349967004993ColpotomizOR Tube SystemCTS35-TV2023-04-04
29349967005006ColpotomizOR Tube SystemCTS45-TV2023-04-04
09349967000724LapPakORW-18W-182018-06-23
09349967001448ColpotomizOR Tube35mmC35-TV2017-11-16
09349967001479ColpotomizOR Tube45mmC45-TV2017-11-16
09349967002261Uterine ElevatOR ProUE-TVPRO-322017-07-19
09349967002292Uterine ElevatOR ProUE-TVPRO-352017-07-19
09349967002322Uterine ElevatOR ProUE-TVPRO-372017-07-19
09349967002353Uterine ElevatOR ProUE-TVPRO-402017-07-19
09349967002773Uterine ElevatOR ProUE-TVPRO-322018-01-31
09349967002803Uterine ElevatOR ProUE-TVPRO-352018-01-31

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