American Medical

GUDID B356FH454070

American Medicals

Orthopaedic chisel

• Primary Device ID: B356FH454070
• NIH Device Record Key: 2fd298db-9177-4724-9c59-37f93fdf8ad2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: American Medical
• Version Model Number: 1
• Company DUNS: 109909627
• Company Name: American Medicals
• 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: false
• Serial Number: false
• Manufacturing Date: false
• 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	B356FH454070 [Primary]

FDA Product Code

• FZO: Chisel, Surgical, Manual

Sterilization

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

[B356FH454070]

Microwave Radiation

[B356FH454070]

Microwave Radiation

[B356FH454070]

Microwave Radiation

[B356FH454070]

Microwave Radiation

[B356FH454070]

Microwave Radiation

[B356FH454070]

Microwave Radiation

[B356FH454070]

Microwave Radiation

[B356FH454070]

Microwave Radiation

[B356FH454070]

Microwave Radiation

[B356FH454070]

Microwave Radiation

[B356FH454070]

Microwave Radiation

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-18
• Device Publish Date: 2025-12-10

Devices Manufactured by American Medicals

• B356FH454070 - American Medical: 2025-12-18
• B356FH454070 - American Medical: 2025-12-18
• B356FH455060 - American Medicals: 2025-12-18
• B356ED107160 - American Medicals: 2025-12-11
• B356JB536280 - American Medicals: 2025-12-03
• B356KD932040 - American Medicals: 2025-09-26
• B356KD932070 - American Medicals: 2025-09-26
• B356KE334280 - American Medicals: 2025-09-23
• B356KJ522130 - American Medicals: 2025-09-22