GUDID 04713025220082

The flexible silicone pessary is commonly used for a mild first or second-degree uterine prolapse or procidentia.

PANPAC MEDICAL CORPORATION

Bladder-supporting pessary
Primary Device ID04713025220082
NIH Device Record Key06aaf107-618c-43ae-8f0c-2197ff40902b
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberRK0-W
Company DUNS657528899
Company NamePANPAC MEDICAL CORPORATION
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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
GS104713025220082 [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 Date2016-08-18

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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