PALABOWL CL006-01BE(CM194-2)

GUDID 06951233720897

Bone Cement Mixing System (Logo: PALABOWL)[Model No.:CL006-01)

Guangzhou Clean Medical Products Manufacturing Corp.

Manual orthopaedic cement mixer, single-use

• Primary Device ID: 06951233720897
• NIH Device Record Key: 9096de5c-958f-4dfa-85e6-6dae278b3549
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PALABOWL
• Version Model Number: CL006-01BE(CM194-2)
• Catalog Number: CL006-01BE(CM194-2)
• Company DUNS: 529707388
• Company Name: Guangzhou Clean Medical Products Manufacturing Corp.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06951233720897 [Primary]

FDA Product Code

• JDZ: Mixer, Cement, For Clinical Use

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: 2024-04-19
• Device Publish Date: 2024-04-11

Devices Manufactured by Guangzhou Clean Medical Products Manufacturing Corp.

• 06951233720842 - PALAGUN®: 2025-06-13 PALAGUN® Bone Cement Mixing System - Disposable Cement Gun [Model NO.:CL006-02]
• 06951233721610 - CLEANEST: 2024-05-23 Bone Cement Mixing System(Vacuum hose with spigot adapter)
• 06951233721634 - CLEANEST: 2024-05-23 Bone Cement Mixing System(Vacuum hose with trumpet adapter)
• 06951233721658 - CLEANEST: 2024-05-23 Bone Cement Mixing System(Vacuum hose with spigot adapter)
• 06951233721665 - CLEANEST: 2024-05-23 Bone Cement Mixing System(Vacuum hose with trumpet adapter)
• 06951233721672 - CLEANEST: 2024-05-23 Bone Cement Mixing System(Vacuum hose with spigot adapter)
• 06951233721696 - CLEANEST: 2024-05-23 Bone Cement Mixing System(Vacuum hose with trumpet adapter)
• 06951233721719 - CLEANEST: 2024-05-23 Bone Cement Mixing System(Vacuum hose with spigot adapter)