FDA.reportPublic FDA data

ColpotomizOR Tube System

Primary DI
09349967000335
Brand
ColpotomizOR Tube System
Company
SURGI SUPPLIES INTERNATIONAL PTY. LTD.
Model
45mm
Catalog number
CTS45-TV
Device description
45mm diameter trans-vaginal tube and uterine manipulator
Published
2016-09-22
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
HEWCuldoscope (And Accessories)
LKFCannula, Manipulator/Injector, Uterine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HEWCuldoscope (And Accessories)Obstetrics/Gynecology2
LKFCannula, Manipulator/Injector, UterineObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09349967000342PackageGS15In Commercial Distribution
09349967000359PackageGS13In Commercial Distribution
09349967000335PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09349967000342093499670003429349967000342
09349967000359093499670003599349967000359
09349967000335093499670003359349967000335

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 Diameter45Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
753476779
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
09349967000007ManipulatORUM-TVUM-TV2016-11-09
09349967000243ColpotomizOR Tube35mmC35-TV2016-09-22
09349967000274ColpotomizOR Tube45mmC45-TV2016-09-22
09349967000304ColpotomizOR Tube System35mmCTS35-TV2016-09-22
09349967000021ManipulatORUM-TVUM-TV2016-11-09
09349967000267ColpotomizOR Tube35mmC35-TV2016-09-22
09349967000298ColpotomizOR Tube45mmC45-TV2016-09-22
09349967000328ColpotomizOR Tube System35mmCTS35-TV2016-09-22

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10607915147812GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access DeviceAPPLIED MEDICAL RESOURCES CORPORATIONHEW2026-04-22
00850011427378Titus Medical LLCTITUS MEDICAL LLCLKF2026-04-20
00850011427385TITUS MEDICALTITUS MEDICAL LLCLKF2026-04-19
00198506017704ELMED INCORPORATEDELMED INCORPORATEDLKF2025-07-08
00860010540930Rejoni Ribbed CatheterRejoni, Inc.LKF2025-02-18
04719894432892BiotequeBioteque Taiwan Ltd.LKF2024-12-06
04719894432908BiotequeBioteque Taiwan Ltd.LKF2024-12-06
04719894432915BiotequeBioteque Taiwan Ltd.LKF2024-12-06
04719894432922BiotequeBioteque Taiwan Ltd.LKF2024-12-06
00840306826177Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2024-05-08
00840306826184Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2024-05-08
04719894432571BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432588BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432595BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432601BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432618BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432625BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432755BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432762BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432779BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432878BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432939BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432885BiotequeBioteque Taiwan Ltd.LKF2024-04-08
00850011427200IMA HSG Catheters TITUS MEDICAL LLCLKF2024-04-03
00850011427187SonoInject Catheter HSGTITUS MEDICAL LLCLKF2024-03-31
00812261016788SALPINX CATHALLWIN MEDICAL DEVICES, INC.LKF2024-01-09
09349967004968Uterine ElevatOR PRO with OccludOR Balloon™THE O R COMPANY PTY LTDLKF2023-05-26
09349967004975Uterine ElevatOR PRO with OccludOR Balloon™THE O R COMPANY PTY LTDLKF2023-05-26
09349967004982Uterine ElevatOR PRO with OccludOR Balloon™THE O R COMPANY PTY LTDLKF2023-05-26
09349967005019Uterine ElevatOR PRO with OccludOR Balloon™THE O R COMPANY PTY LTDLKF2023-05-26