GUDID 04713025222185

Fitting Set is used to determine the proper type and size of pessary for each patient.

PANPAC MEDICAL CORPORATION

Bladder-supporting pessary Bladder-supporting pessary Bladder-supporting pessary Bladder-supporting pessary Bladder-supporting pessary Bladder-supporting pessary Bladder-supporting pessary Bladder-supporting pessary Bladder-supporting pessary Bladder-supporting pessary Bladder-supporting pessary Bladder-supporting pessary Bladder-supporting pessary Bladder-supporting pessary Bladder-supporting pessary Bladder-supporting pessary Bladder-supporting pessary Bladder-supporting pessary Bladder-supporting pessary

• Primary Device ID: 04713025222185
• NIH Device Record Key: b084eddf-e47b-48d9-8cb5-31da2a888399
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: FS1100
• Company DUNS: 657528899
• Company Name: PANPAC MEDICAL CORPORATION
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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	04713025222185 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092981

FDA Product Code

• HHW: Pessary, Vaginal

Sterilization

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

[04713025222185]

Moist Heat or Steam Sterilization

[04713025222185]

Moist Heat or Steam Sterilization

[04713025222185]

Moist Heat or Steam Sterilization

[04713025222185]

Moist Heat or Steam Sterilization

[04713025222185]

Moist Heat or Steam Sterilization

[04713025222185]

Moist Heat or Steam Sterilization

[04713025222185]

Moist Heat or Steam Sterilization

[04713025222185]

Moist Heat or Steam Sterilization

[04713025222185]

Moist Heat or Steam Sterilization

[04713025222185]

Moist Heat or Steam Sterilization

[04713025222185]

Moist Heat or Steam Sterilization

[04713025222185]

Moist Heat or Steam Sterilization

[04713025222185]

Moist Heat or Steam Sterilization

[04713025222185]

Moist Heat or Steam Sterilization

[04713025222185]

Moist Heat or Steam Sterilization

[04713025222185]

Moist Heat or Steam Sterilization

[04713025222185]

Moist Heat or Steam Sterilization

[04713025222185]

Moist Heat or Steam Sterilization

[04713025222185]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-14
• Device Publish Date: 2020-05-06

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.