Eclipse PRP PRP1000-1.Intl

GUDID 00853602008024

Eclipse PRP Patient Kit - 11ml PRP Tube Only (International)

ECLIPSE

Haematological concentrate system

• Primary Device ID: 00853602008024
• NIH Device Record Key: 4c2d38e0-2803-4aa1-9672-f1905c21974d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eclipse PRP
• Version Model Number: PRP1000-1.Intl
• Catalog Number: PRP1000-1.Intl
• Company DUNS: 969752364
• Company Name: ECLIPSE
• 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: true
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853602008024 [Primary]

FDA Product Code

• ORG: Platelet And Plasma Separator For Bone Graft Handling

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: 2018-11-05
• Device Publish Date: 2018-10-04

On-Brand Devices [Eclipse PRP ]

• 00853602008062: Eclipse PRP Patient Kit - 11ml PRP Tube & Blood Draw Kit (International)
• 00853602008055: Eclipse PRP Patient Kit - 11ml PRP Tube & Blood Draw Kit (Canada)
• 00853602008048: Eclipse PRP Blood Draw Kit for 11ml PRP Tubes (Canada)
• 00853602008031: Eclipse PRP Blood Draw Kit for 11ml PRP Tubes
• 00853602008024: Eclipse PRP Patient Kit - 11ml PRP Tube Only (International)
• 00853602008017: Eclipse PRP Patient Kit - 11ml PRP Tube Only
• 00853602008000: Eclipse PRP Patient Kit - 11ml PRP Tube & Blood Draw Kit