The O.R. Company LLC

GUDID 04715309122884

"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
Primary Device ID04715309122884
NIH Device Record Key8619aadb-d300-45be-ba68-994931d2b1ad
Commercial Distribution StatusIn Commercial Distribution
Brand NameThe O.R. Company LLC
Version Model NumberUMI 4.5KC-D
Company DUNS657528899
Company NamePANPAC MEDICAL CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+866286472242
Emailservice@panpac.com.tw
Phone+866286472242
Emailservice@panpac.com.tw
Phone+866286472242
Emailservice@panpac.com.tw
Phone+866286472242
Emailservice@panpac.com.tw
Phone+866286472242
Emailservice@panpac.com.tw
Phone+866286472242
Emailservice@panpac.com.tw
Phone+866286472242
Emailservice@panpac.com.tw
Phone+866286472242
Emailservice@panpac.com.tw
Phone+866286472242
Emailservice@panpac.com.tw
Phone+866286472242
Emailservice@panpac.com.tw
Phone+866286472242
Emailservice@panpac.com.tw
Phone+866286472242
Emailservice@panpac.com.tw
Phone+866286472242
Emailservice@panpac.com.tw
Phone+866286472242
Emailservice@panpac.com.tw
Phone+866286472242
Emailservice@panpac.com.tw
Phone+866286472242
Emailservice@panpac.com.tw
Phone+866286472242
Emailservice@panpac.com.tw
Phone+866286472242
Emailservice@panpac.com.tw
Phone+866286472242
Emailservice@panpac.com.tw

Device Identifiers

Device Issuing AgencyDevice ID
GS104715309122884 [Package]
Contains: 04715309122914
Package: BOX [12 Units]
In Commercial Distribution
GS104715309122914 [Primary]
GS104715309122921 [Package]
Package: carton [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LKFCannula, Manipulator/Injector, Uterine

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-15

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

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