SoftFil® Precision

GUDID 10669808002325

SoftFil® Precision are sterile and single use injection kits containing: - 1 stainless steel pre-hole needle in its protective cap, - 1 stainless steel, graduated blunt-tip needle (micro-cannula) 25G x 50 mm in its protective cap.

Prollenium Medical

Tissue injection cannula

• Primary Device ID: 10669808002325
• NIH Device Record Key: 2f7ae9c2-cf07-4c5f-8f34-f5cba3a1e28c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SoftFil® Precision
• Version Model Number: CP2550U
• Company DUNS: 247326606
• Company Name: Prollenium Medical
• Device Count: 4
• 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	10669808002325 [Unit of Use]
GS1	10669808004084 [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: 2025-09-05
• Device Publish Date: 2025-08-28

On-Brand Devices [SoftFil® Precision]

• 10669808002684: SoftFil® Precision are sterile and single use injection kits containing: - 1 stainless steel pr
• 10669808002677: SoftFil® Precision are sterile and single use injection kits containing: - 1 stainless steel pr
• 10669808002660: SoftFil® Precision are sterile and single use injection kits containing: - 1 stainless steel pr
• 10669808002653: SoftFil® Precision are sterile and single use injection kits containing: - 1 stainless steel pr
• 10669808002646: SoftFil® Precision are sterile and single use injection kits containing: - 1 stainless steel pr
• 10669808002639: SoftFil® Precision are sterile and single use injection kits containing: - 1 stainless steel pr
• 10669808002622: SoftFil® Precision are sterile and single use injection kits containing: - 1 stainless steel pr
• 10669808002615: SoftFil® Precision are sterile and single use injection kits containing: - 1 stainless steel pr
• 10669808002608: SoftFil® Precision are sterile and single use injection kits containing: - 1 stainless steel pr
• 10669808002592: SoftFil® Precision are sterile and single use injection kits containing: - 1 stainless steel pr
• 10669808002585: SoftFil® Precision are sterile and single use injection kits containing: - 1 stainless steel pr
• 10669808002578: SoftFil® Precision are sterile and single use injection kits containing: - 1 stainless steel pr
• 10669808002561: SoftFil® Precision are sterile and single use injection kits containing: - 1 stainless steel pr
• 10669808002554: SoftFil® Precision are sterile and single use injection kits containing: - 1 stainless steel pr
• 10669808002547: SoftFil® Precision are sterile and single use injection kits containing: - 1 stainless steel pr
• 10669808002530: SoftFil® Precision are sterile and single use injection kits containing: - 1 stainless steel pr
• 10669808002523: SoftFil® Precision are sterile and single use injection kits containing: - 1 stainless steel pr
• 10669808002516: SoftFil® Precision are sterile and single use injection kits containing: - 1 stainless steel pr
• 10669808002509: SoftFil® Precision are sterile and single use injection kits containing: - 1 stainless steel pr
• 10669808002493: SoftFil® Precision are sterile and single use injection kits containing: - 1 stainless steel pr
• 10669808002486: SoftFil® Precision are sterile and single use injection kits containing: - 1 stainless steel pr
• 10669808002479: SoftFil® Precision are sterile and single use injection kits containing: - 1 stainless steel pr
• 10669808002325: SoftFil® Precision are sterile and single use injection kits containing: - 1 stainless steel pr