Eclipse PRP HC PRP2000-1.Intl

GUDID 00853602008093

Eclipse PRP HC Patient Kit - 22ml PRP Tube Only (International)

ECLIPSE

Haematological concentrate system

• Primary Device ID: 00853602008093
• NIH Device Record Key: 88577d12-32b0-4468-a41b-bb0d49f5704b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eclipse PRP HC
• Version Model Number: PRP2000-1.Intl
• Catalog Number: PRP2000-1.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

Device Dimensions

• Height: 3.125 Inch
• Height: 3.125 Inch
• Height: 3.125 Inch
• Height: 3.125 Inch

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853602008093 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK110035

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 HC ]

• 00853602008307: 22ml Blood Draw Supply Kit (No Female-Female Adapter)
• 00853602008291: 22ml Blood Draw Supply Kit (International)
• 00853602008284: 22ml Vacutainer Holder + 21 Gauge 3/4 Inch Needle Length Safety Butterfly Needle 12 Inch Tubing
• 00853602008147: 22ml Blood Draw Supply Kit (Canada)
• 00853602008130: 22ml Blood Draw Supply Kit
• 00853602008123: Eclipse PRP HC Patient Kit - 22ml PRP Tube & Blood Draw Kit (International)
• 00853602008116: Eclipse PRP HC Patient Kit - 22ml PRP Tube & Blood Draw Kit (Canada)
• 00853602008109: Eclipse PRP Blood Draw Kit for 22ml Tubes
• 00853602008093: Eclipse PRP HC Patient Kit - 22ml PRP Tube Only (International)
• 00853602008086: Eclipse PRP HC Patient Kit - 22ml PRP Tube Only
• 00853602008079: Eclipse PRP HC Patient Kit - 22ml PRP Tube & Blood Draw Kit
• 00853602008161: 22ml Vacutainer Holder + 21 Gauge 3/4 Inch Needle Length Safety Butterfly Needle 12 Inch Tubing
• 00853602008154: Eclipse PRP Blood Draw Kit - Includes 1-22ml Blood Draw Kit for use with 22ml PRP Tube (Internat