DEVICE: NA (04715309125052)

Device Identifier (DI) Information

NA
BA07F
In Commercial Distribution

PANPAC MEDICAL CORPORATION
04715309125052
GS1

1
657528899 *Terms of Use
HSG catheter sets can be used for sonohysterography and hysterosalpingography procedures that greatly enhance the analysis of uterine pathology. Using HSG balloon catheters, the procedures are simple and non-traumatic for your patients. A placement sheath eliminates the need for a tenaculum. HSG catheters are designed for single patient use only.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
Yes
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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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FDA Product Code

[?]
Product Code Product Code Name
LKF Cannula, Manipulator/Injector, Uterine
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K092983 000
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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

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Size Type Text
No Device Sizes
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Device Record Status

1a5302d7-03fd-4f83-b30d-4ac7d8515de3
July 06, 2018
3
August 15, 2016
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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
04715309121894 10 04715309125052 In Commercial Distribution 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
Yes
No CLOSE

Customer Contact

[?]
+866286472242
service@panpac.com.tw
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