Prism Safety Capsule System

Basic Information

• Brand Name: Prism Safety Capsule System
• Primary DI: 00869997000109
• Version / Model: Prism100
• Catalog Number: Prism100
• Company Name: Prism Medical & Design
• Labeler DUNS: 085927964
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-14
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 495d3dac-1bd8-4120-ad2e-d77c0dbd0084

Device Description

Safety Needle Recapper

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMI	Needle, Hypodermic, Single Lumen	General Hospital	880.5570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36187	Needle recapping device, single-use	A device intended to hold a needle cap and allow a user to conveniently recap a needle, providing some user protection against needle sticks. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00869997000109	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Total Volume	30	Cubic Inch

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 41 – 104 Degrees Fahrenheit