OSTEOTOME, 7", 4mm, OFFSET, HEXED HANDLE

GUDID D9282001493H0

W.H. Holden, Inc.

Dental osteotome

• Primary Device ID: D9282001493H0
• NIH Device Record Key: 5c930039-c36c-498f-a8d6-dc0a35b39e47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSTEOTOME, 7", 4mm, OFFSET, HEXED HANDLE
• Version Model Number: 20-0149-3H
• 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	D9282001493H0 [Primary]

FDA Product Code

• EMM: Chisel, Osteotome, Surgical

Sterilization

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

[D9282001493H0]

Moist Heat or Steam Sterilization

[D9282001493H0]

Moist Heat or Steam Sterilization

[D9282001493H0]

Moist Heat or Steam Sterilization

[D9282001493H0]

Moist Heat or Steam Sterilization

[D9282001493H0]

Moist Heat or Steam Sterilization

[D9282001493H0]

Moist Heat or Steam Sterilization

[D9282001493H0]

Moist Heat or Steam Sterilization

[D9282001493H0]

Moist Heat or Steam Sterilization

[D9282001493H0]

Moist Heat or Steam Sterilization

[D9282001493H0]

Moist Heat or Steam Sterilization

[D9282001493H0]

Moist Heat or Steam Sterilization

[D9282001493H0]

Moist Heat or Steam Sterilization

[D9282001493H0]

Moist Heat or Steam Sterilization

[D9282001493H0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-14
• Device Publish Date: 2026-01-06

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• D928400102HF0 - PERIO KNIFE GOLDMAN FOX 11 HF HANDLE: 2026-01-22
• D928400102R0 - PERIO KNIFE GOLDMAN FOX 11 ROUND HANDLE: 2026-01-22
• D9284001040 - D9284001040: 2026-01-22
• D928100600962DLC0 - EXTRACTION FORCEPS #962 UPPER DLC: 2026-01-14