DEVICE: The O.R. Company LLC (04715309122891)

Download: XML | JSON

Device Identifier (DI) Information

The O.R. Company LLC
UMI 4.5C-D

PANPAC MEDICAL CORPORATION
04715309122891
GS1
1
"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. "
CLOSE

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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
LKF Cannula, Manipulator/Injector, Uterine
CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Status

In Commercial Distribution
August 15, 2016

CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
04715309122877 12 04715309122891 In Commercial Distribution BOX
04715309122907 10 04715309122877 In Commercial Distribution Carton
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

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