AMERICAN ORTHODONTICS

GUDID 00840018600157

AO TYME SHUTTER TOOL

NORDENT MANUFACTURING INC

Orthodontic ligature director

• Primary Device ID: 00840018600157
• NIH Device Record Key: cd587002-400c-4619-be22-0e2c8e2ccf1f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMERICAN ORTHODONTICS
• Version Model Number: 010-255
• Company DUNS: 053187985
• Company Name: NORDENT MANUFACTURING 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: true
• 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
GS1	00840018600157 [Primary]

FDA Product Code

• ECP: Instrument, Ligature Tucking, Orthodontic

Sterilization

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

[00840018600157]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-06
• Device Publish Date: 2020-04-28

On-Brand Devices [AMERICAN ORTHODONTICS]

• 00840018600201: ORTHO ORGANIZERS PLACE/EXPLORER
• 00840018600195: AO BAND PLUGGER / CEMENT SCALER
• 00840018600188: AO USA FE/LD EXPLORER/LIG. DIRECTOR
• 00840018600171: AO USA BAND SEATER N114, DL HEX HANDLE
• 00840018600164: AO TYME SHUTTER TOOL SHORT HNDL.
• 00840018600157: AO TYME SHUTTER TOOL
• 00840018600140: AO CONDENSER BLK7/SPECIAL CN
• 00840018600133: AO MIRROR HANDLE M10
• 00840018600126: AO SE EXPLORER 23
• 00840018600119: AO DISTAL TWISTER .021 X .025
• 00840018600102: AO WIRE TWISTER SMALL SIZE
• 00840018600096: AO SCALER SPECIAL U15/CI1