GUDID 04715309122259

The Inflatable Dount Pessary is effective support in second- or third-degree prolapsed, and also effective in patients with mild cystocele or rectocel

PANPAC MEDICAL CORPORATION

Bladder-supporting pessary
Primary Device ID04715309122259
NIH Device Record Keydb1dcafa-e5f6-45d3-9c47-dddaeb0ea390
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberID2
Company DUNS657528899
Company NamePANPAC MEDICAL CORPORATION
Device Count1
DM Exempttrue
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 Latexfalse
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
GS104715309122259 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HHWPessary, Vaginal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

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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