GUDID 04715309125090

Reusable Cervical Dilators may be reused after disinfecting. They are made of medical-grade Teflon.

PANPAC MEDICAL CORPORATION

Fixed-diameter cervical dilator, reusable

• Primary Device ID: 04715309125090
• NIH Device Record Key: ae729520-7bd2-4ef0-947e-6882a4c1bb9c
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: OS260BA
• Company DUNS: 657528899
• Company Name: PANPAC MEDICAL CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: false
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +866286472242
• Email: service@panpac.com.tw

Device Identifiers

Device Issuing Agency	Device ID
GS1	04715309122099 [Primary]
GS1	04715309125090 [Package]; Contains: 04715309122099; Package: BOX [25 Units]; In Commercial Distribution

FDA Product Code

• HDQ: Dilator, Cervical, Fixed Size

Sterilization

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

[04715309125090]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-08-15

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