S-12 RIWOSpine

GUDID J021304700000

Surgical Handpiece 1:2 for RIWOSpine

W & H Dentalwerk Bürmoos GmbH

Drilling power tool attachment, basic

• Primary Device ID: J021304700000
• NIH Device Record Key: 76714d6c-eade-49c1-93ad-8bb533ebe09d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: S-12 RIWOSpine
• Version Model Number: 30470000
• Company DUNS: 300238441
• Company Name: W & H Dentalwerk Bürmoos GmbH
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J021304700000 [Direct Marking]
HIBCC	J021304700001 [Primary]

FDA Product Code

• ERL: Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

Sterilization

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

[J021304700000]

Moist Heat or Steam Sterilization

[J021304700000]

Moist Heat or Steam Sterilization

[J021304700000]

Moist Heat or Steam Sterilization

[J021304700000]

Moist Heat or Steam Sterilization

[J021304700000]

Moist Heat or Steam Sterilization

[J021304700000]

Moist Heat or Steam Sterilization

[J021304700000]

Moist Heat or Steam Sterilization

[J021304700000]

Moist Heat or Steam Sterilization

[J021304700000]

Moist Heat or Steam Sterilization

[J021304700000]

Moist Heat or Steam Sterilization

[J021304700000]

Moist Heat or Steam Sterilization

[J021304700000]

Moist Heat or Steam Sterilization

[J021304700000]

Moist Heat or Steam Sterilization

[J021304700000]

Moist Heat or Steam Sterilization

[J021304700000]

Moist Heat or Steam Sterilization

[J021304700000]

Moist Heat or Steam Sterilization

[J021304700000]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-15
• Device Publish Date: 2024-02-07

Devices Manufactured by W & H Dentalwerk Bürmoos GmbH

• J021305030001 - Piezomed Pro Accessory: 2025-09-30 Instrument MP1-S
• J021305030011 - Piezomed Pro Accessory: 2025-09-30 Instrument MR1-S
• J021305030021 - Piezomed Pro Accessory: 2025-09-30 Instrument MR2-S
• J021305030031 - Piezomed Pro Accessory: 2025-09-30 Instrument MR3-S
• J021305030041 - Piezomed Pro Accessory: 2025-09-30 Instrument MR4-S
• J021305030051 - Piezomed Pro Accessory: 2025-09-30 Instrument MR5-S
• J021305030061 - Piezomed Pro Accessory: 2025-09-30 Instrument MR6-S
• J021305030071 - Piezomed Pro Accessory: 2025-09-30 Instrument MS1-S