IDR KIT ACCORDING TO DR. ROSA

GUDID D9281790900

W.H. Holden, Inc.

Dental osteotome

• Primary Device ID: D9281790900
• NIH Device Record Key: efd1eceb-e106-4298-8344-b06d7e9a5d0e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IDR KIT ACCORDING TO DR. ROSA
• Version Model Number: 1790-90
• Company DUNS: 183854322
• Company Name: W.H. Holden, 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: false
• Manufacturing Date: true
• Expiration Date: false
• 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
HIBCC	D9281790900 [Primary]

FDA Product Code

• EMM: Chisel, Osteotome, Surgical

Sterilization

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

[D9281790900]

Moist Heat or Steam Sterilization

[D9281790900]

Moist Heat or Steam Sterilization

[D9281790900]

Moist Heat or Steam Sterilization

[D9281790900]

Moist Heat or Steam Sterilization

[D9281790900]

Moist Heat or Steam Sterilization

[D9281790900]

Moist Heat or Steam Sterilization

[D9281790900]

Moist Heat or Steam Sterilization

[D9281790900]

Moist Heat or Steam Sterilization

[D9281790900]

Moist Heat or Steam Sterilization

[D9281790900]

Moist Heat or Steam Sterilization

[D9281790900]

Moist Heat or Steam Sterilization

[D9281790900]

Moist Heat or Steam Sterilization

[D9281790900]

Moist Heat or Steam Sterilization

[D9281790900]

Moist Heat or Steam Sterilization

[D9281790900]

Moist Heat or Steam Sterilization

[D9281790900]

Moist Heat or Steam Sterilization

[D9281790900]

Moist Heat or Steam Sterilization

[D9281790900]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-26
• Device Publish Date: 2024-12-18

Devices Manufactured by W.H. Holden, Inc.

• D928P0112810 - X-NAV, HANDPIECE CALIBRATION BIT LATCH, SZ-75: 2025-01-23
• D9283001080 - SCISSORS OPERATING 6" CRV. S/S TC: 2024-12-27
• D9283001090 - SCISSORS MAYO 5 1/2" STRAIGHT TC: 2024-12-27
• D9283001100 - SCISSORS MAYO 5 1/2" CURVED TC: 2024-12-27
• D9283001110 - SCISSORS MAYO 6 3/4" STRAIGHT TC: 2024-12-27
• D9283001120 - SCISSORS MAYO 6 3/4" CURVED TC: 2024-12-27
• D9283001150 - SCISSORS METZENBAUM 5 3/4" STRAIGHT BLUNT TC: 2024-12-27
• D9283001160 - SCISSORS METZ 5 3/4" CURVED TC: 2024-12-27