AccessGUDID - DEVICE: NA (04715309125236)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: UMI 4.5KC
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PANPAC MEDICAL CORPORATION

Primary DI Number: 04715309125236
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 657528899 *Terms of Use

Device Description: "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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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.	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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4d564271-9ce7-4e57-b0cb-67c075de49df
Public Version Date: November 07, 2022
Public Version Number: 5
DI Record Publish Date: August 15, 2016