Osteotome 7452-66

GUDID 00840199527731

Anterior Osteotome 16mm Straight 43cm 17" Length

KOROS U.S.A., INC.

Orthopaedic osteotome

• Primary Device ID: 00840199527731
• NIH Device Record Key: eb813189-7953-48ca-a55a-520b50e47fb3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Osteotome
• Version Model Number: 7452-66
• Catalog Number: 7452-66
• Company DUNS: 007928633
• Company Name: KOROS U.S.A., INC.
• 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: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com
• Phone: 1-805-529-0825
• Email: customerservice@korosUSA.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840199527731 [Direct Marking]
GS1	10840199527738 [Primary]

FDA Product Code

• KDG: Chisel (Osteotome)

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00840199527731]

Moist Heat or Steam Sterilization

[00840199527731]

Moist Heat or Steam Sterilization

[00840199527731]

Moist Heat or Steam Sterilization

[00840199527731]

Moist Heat or Steam Sterilization

[00840199527731]

Moist Heat or Steam Sterilization

[00840199527731]

Moist Heat or Steam Sterilization

[00840199527731]

Moist Heat or Steam Sterilization

[00840199527731]

Moist Heat or Steam Sterilization

[00840199527731]

Moist Heat or Steam Sterilization

[00840199527731]

Moist Heat or Steam Sterilization

[00840199527731]

Moist Heat or Steam Sterilization

[00840199527731]

Moist Heat or Steam Sterilization

[00840199527731]

Moist Heat or Steam Sterilization

[00840199527731]

Moist Heat or Steam Sterilization

[00840199527731]

Moist Heat or Steam Sterilization

[00840199527731]

Moist Heat or Steam Sterilization

[00840199527731]

Moist Heat or Steam Sterilization

[00840199527731]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-08
• Device Publish Date: 2024-01-31

On-Brand Devices [Osteotome]

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• 00840199527847: Koros-Scaglietti Long Osteotome 16mm Curved 28cm 11" Length
• 00840199527830: Koros-Scaglietti Long Osteotome 12mm Curved 28cm 11" Length
• 10840199527820: Koros-Scaglietti Long Osteotome 9mm Curved 28cm 11" Length
• 00840199527816: Koros-Scaglietti Long Osteotome 6mm Curved 28cm 11" Length
• 00840199527809: Koros-Scaglietti Osteotome 19mm Curved 22cm 8-1/2" Length
• 00840199527793: Koros-Scaglietti Osteotome 16mm Curved 22cm 8-1/2" Length
• 00840199527786: Koros-Scaglietti Osteotome 12mm Curved 22cm 8-1/2" Length
• 00840199527779: Koros-Scaglietti Osteotome 9mm Curved 22cm 8-1/2" Length
• 00840199527762: Koros-Scaglietti Osteotome 6mm Curved 22cm 8-1/2" Length
• 00840199527748: Anterior Osteotomes 19mm Straight 43cm 17" Length
• 00840199527731: Anterior Osteotome 16mm Straight 43cm 17" Length
• 00840199527724: Anterior Osteotome 12mm Straight 43cm 17" Length
• 10840199527714: Anterior Osteotomes 9mm Straight 43cm 17" Length
• 00840199527700: Anterior Osteotomes 6mm Straight 43cm 17" Length
• 00840199527670: Koros-Scaglietti Long Osteotome 19mm Straight 28cm 11" Length
• 00840199527663: Koros-Scaglietti Long Osteotome 16mm Straight 28cm 11" Length
• 00840199527656: Koros-Scaglietti Long Osteotome 12mm Straight 28cm 11" Length
• 00840199527649: Koros-Scaglietti Long Osteotome 9mm Straight 28cm 11" Length
• 00840199523450: Spinal Delicate Osteotome Curved 10mm, 32cm Length
• 00840199523443: Spinal Delicate Osteotome Straight Tip 10mm, 32cm Length
• 00840199522989: Lateral Osteotome Straight Tip with Microscope Handle 10mm, 7-1/2" Shaft 19cm, 5-1/2" 14cm Handl
• 00840199522286: Lateral Osteotome Straight Tip with Microscope Handle, 10mm, 7-1/2" Shaft 19cm, 5-1/2" 14cm Hand
• 00840199522279: Lateral Osteotome Straight Tip with Offset Handle, 10mm, 8-1/2" Shaft 21.5cm, 9-3/4" 25cm Handle
• 00840199522262: Lateral Osteotome Straight Tip with Straight Handle, 10mm, 8-1/2" Shaft 21.5cm, 9-1/2" 24cm Hand
• 00840199527632: Scaglietti Long Osteotome 6mm Straight 11"/28cm
• 00840199527601: Koros-Scaglietti Osteotome 19mm Straight 22cm 8-1/2" Length
• 00840199527595: Koros-Scaglietti Osteotome 16mm Straight 22cm 8-1/2" Length
• 00840199527588: Koros-Scaglietti Osteotome 12mm Straight 22cm 8-1/2" Length
• 00840199527571: Koros-Scaglietti Osteotome 9mm Straight 22cm 8-1/2" Length
• 00840199527564: Koros-Scaglietti Osteotome 6mm Straight 22cm 8-1/2" Length
• 00840199527489: Coughlin Osteotome Curved 12mm Tip, 19.5cm Length
• 00840199527472: Coughlin Osteotome Curved 10mm Tip, 19.5cm Length
• 00840199527465: Coughlin Osteotome Curved 8mm Tip, 19.5cm Length
• 00840199527458: Coughlin Osteotome Curved 6mm Tip, 19.5cm Length
• 00840199527441: Coughlin Osteotome Curved 4mm Tip, 19.5cm Length
• 00840199527434: Coughlin Osteotome Straight 12mm Tip, 19.5cm Length
• 00840199527427: Coughlin Osteotome Straight 10mm Tip, 19.5c Length
• 00840199527410: Coughlin Osteotome Straight 8mm Tip, 19.5cm Length
• 00840199527403: Coughlin Osteotome Straight 6mm Tip, 19.5cm Length
• 00840199527397: Coughlin Osteotome Straight 4mm Tip, 19.5cm Length