IVRO RETRACTOR, TWO PIECES

GUDID D9289101400

W.H. Holden, Inc.

Surgical drill guide, reusable

• Primary Device ID: D9289101400
• NIH Device Record Key: a2200a5a-5b48-4105-876b-0563438a4e84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IVRO RETRACTOR, TWO PIECES
• Version Model Number: 91-0140
• 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	D9289101400 [Primary]

FDA Product Code

• FZX: Guide, Surgical, Instrument

Sterilization

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

[D9289101400]

Moist Heat or Steam Sterilization

[D9289101400]

Moist Heat or Steam Sterilization

[D9289101400]

Moist Heat or Steam Sterilization

[D9289101400]

Moist Heat or Steam Sterilization

[D9289101400]

Moist Heat or Steam Sterilization

[D9289101400]

Moist Heat or Steam Sterilization

[D9289101400]

Moist Heat or Steam Sterilization

[D9289101400]

Moist Heat or Steam Sterilization

[D9289101400]

Moist Heat or Steam Sterilization

[D9289101400]

Moist Heat or Steam Sterilization

[D9289101400]

Moist Heat or Steam Sterilization

[D9289101400]

Moist Heat or Steam Sterilization

[D9289101400]

Moist Heat or Steam Sterilization

[D9289101400]

Moist Heat or Steam Sterilization

[D9289101400]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-02
• Device Publish Date: 2025-04-24

Devices Manufactured by W.H. Holden, Inc.

• D928400527H0 - POWERTOME S/E HF HANDLE: 2026-02-04
• D928106122R450 - SUCTION TIP #2-REGULAR - 45DEG RIGHT GRIND ANGLE: 2026-01-23
• D9281059552HF570 - CURETTE SINUS LARGE PADDLE SHARP, SMALL PADDLE DULL, D/E HANDFORM HANDLE LONG: 2026-01-22
• D928400101CH0 - PERIO KNIFE GOLDMAN FOX 8 CH HANDLE: 2026-01-22
• D928400102CH0 - PERIO KNIFE GOLDMAN FOX 11 CH HANDLE: 2026-01-22
• 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