The O.R. Company LLC

GUDID 04715309122877

"Manipulator is a simple, safe and effective device for Diagnostic Laparoscopy, Minilaparotomy, Fertility Exams, and Salpingoplasty. It also helps

PANPAC MEDICAL CORPORATION

Hysterosonography/endometrial biopsy catheter Hysterosonography/endometrial biopsy catheter Hysterosonography/endometrial biopsy catheter Hysterosonography/endometrial biopsy catheter Hysterosonography/endometrial biopsy catheter Hysterosonography/endometrial biopsy catheter Hysterosonography/endometrial biopsy catheter Hysterosonography/endometrial biopsy catheter Hysterosonography/endometrial biopsy catheter Hysterosonography/endometrial biopsy catheter Hysterosonography/endometrial biopsy catheter Hysterosonography/endometrial biopsy catheter Hysterosonography/endometrial biopsy catheter Hysterosonography/endometrial biopsy catheter Hysterosonography/endometrial biopsy catheter Hysterosonography/endometrial biopsy catheter Hysterosonography/endometrial biopsy catheter Hysterosonography/endometrial biopsy catheter Hysterosonography/endometrial biopsy catheter

• Primary Device ID: 04715309122877
• NIH Device Record Key: 3dd64f58-03dd-4cb4-aa8f-d8ffe174f2f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: The O.R. Company LLC
• Version Model Number: UMI 4.5C-D
• Company DUNS: 657528899
• Company Name: PANPAC MEDICAL CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +866286472242
• Email: service@panpac.com.tw
• Phone: +866286472242
• Email: service@panpac.com.tw
• Phone: +866286472242
• Email: service@panpac.com.tw
• Phone: +866286472242
• Email: service@panpac.com.tw
• Phone: +866286472242
• Email: service@panpac.com.tw
• Phone: +866286472242
• Email: service@panpac.com.tw
• Phone: +866286472242
• Email: service@panpac.com.tw
• Phone: +866286472242
• Email: service@panpac.com.tw
• Phone: +866286472242
• Email: service@panpac.com.tw
• Phone: +866286472242
• Email: service@panpac.com.tw
• Phone: +866286472242
• Email: service@panpac.com.tw
• Phone: +866286472242
• Email: service@panpac.com.tw
• Phone: +866286472242
• Email: service@panpac.com.tw
• Phone: +866286472242
• Email: service@panpac.com.tw
• Phone: +866286472242
• Email: service@panpac.com.tw
• Phone: +866286472242
• Email: service@panpac.com.tw
• Phone: +866286472242
• Email: service@panpac.com.tw
• Phone: +866286472242
• Email: service@panpac.com.tw
• Phone: +866286472242
• Email: service@panpac.com.tw

Device Identifiers

Device Issuing Agency	Device ID
GS1	04715309122877 [Package]; Contains: 04715309122891; Package: BOX [12 Units]; In Commercial Distribution
GS1	04715309122891 [Primary]
GS1	04715309122907 [Package]; Package: Carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092980

FDA Product Code

• LKF: Cannula, Manipulator/Injector, Uterine

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-15

On-Brand Devices [The O.R. Company LLC]

• 04715309122884: "Manipulator is a simple, safe and effective device for Diagnostic Laparoscopy, Minilaparoto
• 04715309122877: "Manipulator is a simple, safe and effective device for Diagnostic Laparoscopy, Minilaparoto