Prism Safety Capsule System Prism100

GUDID 00869997000109

Safety Needle Recapper

Prism Medical & Design

Needle recapping device, single-use

• Primary Device ID: 00869997000109
• NIH Device Record Key: 495d3dac-1bd8-4120-ad2e-d77c0dbd0084
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prism Safety Capsule System
• Version Model Number: Prism100
• Catalog Number: Prism100
• Company DUNS: 085927964
• Company Name: Prism Medical & Design
• Device Count: 1
• DM Exempt: true
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 754-802-1990
• Email: les@prismmedicaldesign.com

Device Dimensions

• Total Volume: 30 Cubic Inch

Operating and Storage Conditions

• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00869997000109 [Primary]

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-10-14