DEVICE: NA (04715309125069)
Device Identifier (DI) Information
NA
UIC5F
In Commercial Distribution
PANPAC MEDICAL CORPORATION
UIC5F
In Commercial Distribution
PANPAC MEDICAL CORPORATION
The catheter is to be used for sonohysterography procedure that aid in the analysis of uterine pathology. A placement sheath eliminates the need for a tenaculum. This catheter is designed for single patient use.
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? |
---|---|---|---|---|
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 [?] |
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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
e634d787-cc15-4be0-a7d8-da09d7b7ddef
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 |
---|---|---|---|---|---|
04715309121900 | 25 | 04715309125069 | In Commercial Distribution | BOX |
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