INSUFFLATION NEEDLE,12CM IN-12

GUDID 20858690006208

INSUFFLATION NEEDLE,12CM PN 68017-01M

RANFAC CORP.

Spring-loaded pneumoperitoneum needle, single-use

• Primary Device ID: 20858690006208
• NIH Device Record Key: 54a1d125-f725-4e8e-a62a-802f7767c571
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INSUFFLATION NEEDLE,12CM
• Version Model Number: 14GA x 12 CM
• Catalog Number: IN-12
• Company DUNS: 121622872
• Company Name: RANFAC CORP.
• 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: false
• 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: 5085884400
• Email: info@ranfac.com

Device Dimensions

• Length: 12 Centimeter
• Length: 12 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858690006204 [Primary]
GS1	10858690006201 [Package]; Contains: 00858690006204; Package: Inner Pack [10 Units]; In Commercial Distribution
GS1	20858690006208 [Package]; Contains: 10858690006201; Package: Case [16 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K930474

FDA Product Code

• FHO: Pneumoperitoneum Needle

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-05-08

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