GUDID 04715309122044

"The ETO Sterilized Preferred Curette is used to obtain a sample from the uterine mucosal lining. The Preferred Curette is a 3mm (O.D.), or 3.6 mm (O.

PANPAC MEDICAL CORPORATION

Endometrial biopsy kit
Primary Device ID04715309122044
NIH Device Record Key19a57b96-bc18-42da-adaa-fb983ee9c4bb
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberM0014
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
GS104715309122044 [Package]
Contains: 04715309124987
Package: BOX [25 Units]
In Commercial Distribution
GS104715309124987 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HHKCurette, Suction, Endometrial (And Accessories)

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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