DEVICE: The O.R. Company LLC (04715309122914)
Device Identifier (DI) Information
The O.R. Company LLC
UMI 4.5KC-D
In Commercial Distribution
PANPAC MEDICAL CORPORATION
UMI 4.5KC-D
In Commercial Distribution
PANPAC MEDICAL CORPORATION
"Manipulator is a simple, safe and effective device for Diagnostic Laparoscopy, Minilaparotomy, Fertility Exams, and Salpingoplasty. It also helps the sealing of the cervical as while providing a fluid or air to the cuff.
"
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
42912 | Hysterosonography/endometrial biopsy catheter |
A flexible tube designed for combined saline infusion sonohysterography (SIS) and biopsy functionality providing the physician with increased visibility offered by a sonohysterography during a diagnostic image ultrasound and the ability to take a biopsy of endometrial tissue during the same gynaecological procedure. It is introduced via the vagina and allows the uterus to be filled with saline which is retained with an acorn-tipped stopper placed against the cervical opening; a biopsy can be taken if indicated. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LKF | Cannula, Manipulator/Injector, Uterine |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
8619aadb-d300-45be-ba68-994931d2b1ad
November 07, 2022
5
August 15, 2016
November 07, 2022
5
August 15, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
04715309122884 | 12 | 04715309122914 | In Commercial Distribution | BOX | |
04715309122921 | 10 | 04715309122884 | In Commercial Distribution | carton |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+866286472242
service@panpac.com.tw
service@panpac.com.tw