GUDID 04715309121979

The catheter is to be used for sonohysterography procedure that aid in the analysis of uterine pathology. A placement sheath eliminates the need for

PANPAC MEDICAL CORPORATION

Hysterosonography/endometrial biopsy catheter
Primary Device ID04715309121979
NIH Device Record Key0ef344ac-a882-49c0-864f-fe9df2f31a6e
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberUIC5FA
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 Productfalse
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
GS104715309121979 [Package]
Contains: 04715309125151
Package: BOX [25 Units]
In Commercial Distribution
GS104715309125151 [Primary]

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

Devices Manufactured by PANPAC MEDICAL CORPORATION

04713025222093 - NA2020-05-14 Gellhorn pessary is used to relieve the symptoms of cystocele or rectocele and second or third-degree uterine prolapse.
04713025222109 - NA2020-05-14 Gellhorn pessary is used to relieve the symptoms of cystocele or rectocele and second or third-degree uterine prolapse.
04713025222116 - NA2020-05-14 Gellhorn pessary is used to relieve the symptoms of cystocele or rectocele and second or third-degree uterine prolapse.
04713025222123 - NA2020-05-14 Gellhorn pessary is used to relieve the symptoms of cystocele or rectocele and second or third-degree uterine prolapse.
04713025222130 - NA2020-05-14 Gellhorn pessary is used to relieve the symptoms of cystocele or rectocele and second or third-degree uterine prolapse.
04713025222147 - NA2020-05-14 Gellhorn pessary is used to relieve the symptoms of cystocele or rectocele and second or third-degree uterine prolapse.
04713025222154 - NA2020-05-14 Gellhorn pessary is used to relieve the symptoms of cystocele or rectocele and second or third-degree uterine prolapse.
04713025222161 - NA2020-05-14 Gellhorn pessary is used to relieve the symptoms of cystocele or rectocele and second or third-degree uterine prolapse.

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