FDA.reportPublic FDA data

ColpotomizOR Tube

Primary DI
09349967000243
Brand
ColpotomizOR Tube
Company
SURGI SUPPLIES INTERNATIONAL PTY. LTD.
Model
35mm
Catalog number
C35-TV
Device description
35mm diameter trans-vaginal tube
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)

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09349967000250PackageGS15In Commercial Distribution
09349967000267PackageGS13In Commercial Distribution
09349967000243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09349967000250093499670002509349967000250
09349967000267093499670002679349967000267
09349967000243093499670002439349967000243

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

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
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
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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