SoftFil® EasyGuide

GUDID 10669808002455

SoftFil® EasyGuide is a sterile and single use injection kit containing: - 1 stainless steel EasyGuide pre-hole needle in its protective cap, - 1 stainless steel blunt-tip needle (micro-cannula) 25G x 60 mm graduated every centimeter along the tube in its protective cap.

Prollenium Medical

Tissue injection cannula

• Primary Device ID: 10669808002455
• NIH Device Record Key: 7c3804a7-09cb-46b4-b296-a28193588360
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SoftFil® EasyGuide
• Version Model Number: CEGS2560U
• Company DUNS: 247326606
• Company Name: Prollenium Medical
• Device Count: 20
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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	10669808002158 [Unit of Use]
GS1	10669808002455 [Primary]

FDA Product Code

• GEA: Cannula, Surgical, General & Plastic Surgery

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-19
• Device Publish Date: 2022-08-11

On-Brand Devices [SoftFil® EasyGuide]

• 10669808002462: SoftFil® EasyGuide is a sterile and single use injection kit containing: - 1 stainless steel Ea
• 10669808002455: SoftFil® EasyGuide is a sterile and single use injection kit containing: - 1 stainless steel Ea
• 10669808002448: SoftFil® EasyGuide is a sterile and single use injection kit containing: - 1 stainless steel Ea
• 10669808002431: SoftFil® EasyGuide is a sterile and single use injection kit containing: - 1 stainless steel Ea
• 10669808002424: SoftFil® EasyGuide is a sterile and single use injection kit containing: - 1 stainless steel Ea
• 10669808002417: SoftFil® EasyGuide is a sterile and single use injection kit containing: - 1 stainless steel Ea
• 10669808002400: SoftFil® EasyGuide is a sterile and single use injection kit containing: - 1 stainless steel Ea
• 10669808002394: SoftFil® EasyGuide is a sterile and single use injection kit containing: - 1 stainless steel Ea