GUDID 04713025224011

HSG catheters may be used to evaluate the causes of abnormal uterine bleeding, menstrual disorders, recurrent pregnancy loss or unexplained infertilit

PANPAC MEDICAL CORPORATION

Hysterosonography/endometrial biopsy catheter

• Primary Device ID: 04713025224011
• NIH Device Record Key: b51f9099-f376-4337-98f3-fff51d56ff38
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: BA05F-S
• Company DUNS: 657528899
• Company Name: PANPAC MEDICAL CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04713025224004 [Primary]
GS1	04713025224011 [Package]; Contains: 04713025224004; Package: BOX [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092983

FDA Product Code

• LKF: Cannula, Manipulator/Injector, Uterine

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[04713025224011]

Ethylene Oxide

[04713025224011]

Ethylene Oxide

[04713025224011]

Ethylene Oxide

[04713025224011]

Ethylene Oxide

[04713025224011]

Ethylene Oxide

[04713025224011]

Ethylene Oxide

[04713025224011]

Ethylene Oxide

[04713025224011]

Ethylene Oxide

[04713025224011]

Ethylene Oxide

[04713025224011]

Ethylene Oxide

[04713025224011]

Ethylene Oxide

[04713025224011]

Ethylene Oxide

[04713025224011]

Ethylene Oxide

[04713025224011]

Ethylene Oxide

[04713025224011]

Ethylene Oxide

[04713025224011]

Ethylene Oxide

[04713025224011]

Ethylene Oxide

[04713025224011]

Ethylene Oxide

[04713025224011]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-08-09
• Device Publish Date: 2018-07-09

Devices Manufactured by PANPAC MEDICAL CORPORATION

• 04713025222093 - NA: 2020-05-14 Gellhorn pessary is used to relieve the symptoms of cystocele or rectocele and second or third-degree uterine prolapse.
• 04713025222109 - NA: 2020-05-14 Gellhorn pessary is used to relieve the symptoms of cystocele or rectocele and second or third-degree uterine prolapse.
• 04713025222116 - NA: 2020-05-14 Gellhorn pessary is used to relieve the symptoms of cystocele or rectocele and second or third-degree uterine prolapse.
• 04713025222123 - NA: 2020-05-14 Gellhorn pessary is used to relieve the symptoms of cystocele or rectocele and second or third-degree uterine prolapse.
• 04713025222130 - NA: 2020-05-14 Gellhorn pessary is used to relieve the symptoms of cystocele or rectocele and second or third-degree uterine prolapse.
• 04713025222147 - NA: 2020-05-14 Gellhorn pessary is used to relieve the symptoms of cystocele or rectocele and second or third-degree uterine prolapse.
• 04713025222154 - NA: 2020-05-14 Gellhorn pessary is used to relieve the symptoms of cystocele or rectocele and second or third-degree uterine prolapse.
• 04713025222161 - NA: 2020-05-14 Gellhorn pessary is used to relieve the symptoms of cystocele or rectocele and second or third-degree uterine prolapse.