DEVICE: ColpotomizOR Tube (09349967001424)

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Device Record History
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Device Identifier (DI) Information
ColpotomizOR Tube
35mm
In Commercial Distribution
C35-TV
THE O R COMPANY PTY LTD
09349967001424
GS1

1
744346235 *Terms of Use
35mm Diameter Trans-Vaginal Tube, 3 Way Valve and Silicone Tie
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Device Characteristics
Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
47936 Colpotomy tube
A 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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
HEW Culdoscope (And Accessories)
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Outer Diameter: 35 Millimeter
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Device Record Status
614c3dd8-36f5-4d5a-b5e6-2fb919a92817
April 04, 2023
3
November 16, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
09349967001448 3 09349967001431 In Commercial Distribution Shipper box
09349967001431 5 09349967001424 In Commercial Distribution Outer Box
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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