PolyPrep CD-PP-3008-S

GUDID 00840124512962

Osteotome Straight 8mm (Sterile)

FUSION ORTHOPEDICS, LLC

Orthopaedic osteotome

• Primary Device ID: 00840124512962
• NIH Device Record Key: 7de492d5-0e90-4a5f-9642-ba68a56edbd0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PolyPrep
• Version Model Number: CD-PP-3008-S
• Catalog Number: CD-PP-3008-S
• Company DUNS: 080307067
• Company Name: FUSION ORTHOPEDICS, LLC
• Device Count: 1
• DM Exempt: true
• 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: true
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840124512962 [Primary]

FDA Product Code

• HWM: Osteotome

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: 2024-10-15
• Device Publish Date: 2024-10-07

On-Brand Devices [PolyPrep]

• 00840124514195: Push Pull
• 00840124513037: Osteotome Flexible 130mm x 20mm (Sterile)
• 00840124513020: Osteotome Flexible 130mm x 16mm (Sterile)
• 00840124513013: Osteotome Flexible 130mm x 12mm (Sterile)
• 00840124513006: Osteotome Flexible 130mm x 10mm (Sterile)
• 00840124512993: Osteotome Flexible 70mm x 20mm (Sterile)
• 00840124512986: Osteotome Flexible 70mm x 12mm (Sterile)
• 00840124512979: Osteotome Flexible 70mm x 10mm (Sterile)
• 00840124512962: Osteotome Straight 8mm (Sterile)
• 00840124512955: Osteotome Straight 7mm (Sterile)
• 00840124512948: Osteotome Straight 6mm (Sterile)
• 00840124512931: Osteotome Straight 5mm (Sterile)
• 00840124512924: Osteotome Straight 4mm (Sterile)
• 00840124512917: Osteotome Flexible 70mm x 8mm (Sterile)
• 00840124512900: Curette 6mm (Sterile)
• 00840124512894: Curette 5mm (Sterile)
• 00840124512887: Curette 4mm (Sterile)
• 00840124512870: Curette 3mm (Sterile)
• 00840124512863: Pulling Cartilage Remover 8mm (Sterile)
• 00840124512856: Pulling Cartilage Remover 7mm (Sterile)
• 00840124512849: Pulling Cartilage Remover 6mm (Sterile)
• 00840124512832: Pulling Cartilage Remover 5mm (Sterile)
• 00840124512825: Pulling Cartilage Remover 4mm (Sterile)