FDA.reportPublic FDA data

ColpotomizOR Tube System

Primary DI
09349967000328
Brand
ColpotomizOR Tube System
Company
SURGI SUPPLIES INTERNATIONAL PTY. LTD.
Model
35mm
Catalog number
CTS35-TV
Device description
35mm 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
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HEWCuldoscope (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HEWCuldoscope (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09349967000311PackageGS15In Commercial Distribution
09349967000328PackageGS13In Commercial Distribution
09349967000304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09349967000311093499670003119349967000311
09349967000328093499670003289349967000328
09349967000304093499670003049349967000304

GMDN Terms#

Term, Definition table
TermDefinition
Colpotomy tubeA sterile, hand-held, hollow cylindrical device designed to facilitate dissection of the cervical/vaginal junction during total laparoscopic-assisted hysterectomy. It is typically made of plastic material and functions as a transvaginal conduit for surgical instruments and as an anvil-like support during dissection. Its distal end is designed to fit tightly against the cervix, and its proximal end has a seal to prevent loss of peritoneum-distention gas [e.g., carbon dioxide (CO2)] used during the laparoscopic procedure. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter35Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
753476779
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
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
09349967000335ColpotomizOR Tube System45mmCTS45-TV2016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10607915147812GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access DeviceAPPLIED MEDICAL RESOURCES CORPORATIONHEW2026-04-22
19349967004996ColpotomizOR Tube SystemTHE O R COMPANY PTY LTDHEW2023-04-04
19349967005009ColpotomizOR Tube SystemTHE O R COMPANY PTY LTDHEW2023-04-04
29349967004993ColpotomizOR Tube SystemTHE O R COMPANY PTY LTDHEW2023-04-04
29349967005006ColpotomizOR Tube SystemTHE O R COMPANY PTY LTDHEW2023-04-04
10607915145313GelPOINT V-Path APPLIED MEDICAL RESOURCES CORPORATIONHEW2023-03-17
10607915145320GelPOINT V-Path APPLIED MEDICAL RESOURCES CORPORATIONHEW2023-03-17
10607915145337GelPOINT V-Path APPLIED MEDICAL RESOURCES CORPORATIONHEW2023-03-17
10607915146693GelPOINT V-Path APPLIED MEDICAL RESOURCES CORPORATIONHEW2023-03-17
00607915145613GelPOINT V-Path APPLIED MEDICAL RESOURCES CORPORATIONHEW2023-02-17
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20888937015700Ultem Koh Cup Coopersurgical, Inc.HEW2022-12-01
20888937015717Ultem Koh Cup Coopersurgical, Inc.HEW2022-12-01
20888937015724Ultem Koh Cup Coopersurgical, Inc.HEW2022-12-01
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00888937015126RUMI II Koh-EfficientCoopersurgical, Inc.HEW2022-11-10
00888937015133RUMI II Koh-EfficientCoopersurgical, Inc.HEW2022-11-10
00888937015140Arch Koh-Efficient Coopersurgical, Inc.HEW2022-11-10
00888937015157Arch Koh-Efficient Coopersurgical, Inc.HEW2022-11-10
00888937015164Arch Koh-Efficient Coopersurgical, Inc.HEW2022-11-10
00888937015171Arch Koh-Efficient Coopersurgical, Inc.HEW2022-11-10
00888937015188Arch Koh-Efficient Coopersurgical, Inc.HEW2022-11-10
00888937015195Arch Koh-Efficient Coopersurgical, Inc.HEW2022-11-10