Qigenix PRP QIG1000-1

GUDID 00853602008321

Qigenix PRP Patient Kit - 11ml PRP Tube Only

ECLIPSE

Haematological concentrate system

• Primary Device ID: 00853602008321
• NIH Device Record Key: aaf00160-f07a-4ce5-aa8a-a958ecf4b655
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Qigenix PRP
• Version Model Number: QIG1000-1
• Catalog Number: QIG1000-1
• 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	00853602008321 [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

Devices Manufactured by ECLIPSE

• 10853602008397 - Eclipse EVO Microneedling Cartridge: 2022-01-19 MicroPen EVO Turbo Safety Cartridge (Each). Cartridges are sterilized and packaged individually for single patient use.
• 00853602008598 - Eclipse MicroPen EVO: 2022-01-19 Eclipse MicroPen EVO handpiece which is an automated, non-surgical microneedling device designed for use by licensed healthcare
• 00853602008604 - Eclipse Hypodermic Needle - 18G: 2022-01-19 Eclipse 18 Gauge Venting Needle - 18G x 1"; sterilized and individually packaged for single patient use. Venting needle is a com
• 00853602008611 - Eclipse Hypodermic Needle - 30G: 2022-01-19 Eclipse 30G Hypodermic Needle - 30G x 0.5"; sterilized and individually packaged for single patient use.
• 10853602008458 - Eclipse DermaFlex MicroCannula: 2021-03-31 DermaFlex Microcannula 22G/60mm + 21G/25mm
• 00853602008468 - Eclipse DermaFlex MicroCannula: 2021-03-31 DermaFlex Microcannula 22G/70mm + 21G/25mm Pilot
• 10853602008472 - Eclipse DermaFlex MicroCannula: 2021-03-31 DermaFlex Microcannula 25G/40mm + 23G/25mm Pilot
• 10853602008489 - Eclipse DermaFlex MicroCannula: 2021-03-31 DermaFlex Microcannula 25G/50mm + 23G/25mm Pilot