GUDID 04715309122013

These Cervical Dilators are especially useful in locating and dilating the external OS, the cervical canal and the internal OS. They are particularly

PANPAC MEDICAL CORPORATION

Corpus cavernosum dilator, single-use
Primary Device ID04715309122013
NIH Device Record Key4750adc5-55dc-4e73-84a0-48768924634f
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberOS265BA-2
Company DUNS657528899
Company NamePANPAC MEDICAL CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS104715309122013 [Package]
Contains: 04715309125076
Package: BOX [25 Units]
In Commercial Distribution
GS104715309125076 [Primary]

FDA Product Code

HDQDilator, Cervical, Fixed Size

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-08-15

Devices Manufactured by PANPAC MEDICAL CORPORATION

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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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