ProUltra PUWRENCH

GUDID D716PUWRENCH1

PROULTRA KITS - WRENCH

TULSA DENTAL PRODUCTS LLC

Dental torque wrench

• Primary Device ID: D716PUWRENCH1
• NIH Device Record Key: 14df7c29-9af0-45ed-a999-5913522c7272
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProUltra
• Version Model Number: PUWRENCH
• Catalog Number: PUWRENCH
• Company DUNS: 942778564
• Company Name: TULSA DENTAL PRODUCTS LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: 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	D716PUWRENCH1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K960889

FDA Product Code

• ELC: Scaler, ultrasonic

Sterilization

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

[D716PUWRENCH1]

Liquid Chemical

[D716PUWRENCH1]

Liquid Chemical

[D716PUWRENCH1]

Liquid Chemical

[D716PUWRENCH1]

Liquid Chemical

[D716PUWRENCH1]

Liquid Chemical

[D716PUWRENCH1]

Liquid Chemical

[D716PUWRENCH1]

Liquid Chemical

[D716PUWRENCH1]

Liquid Chemical

[D716PUWRENCH1]

Liquid Chemical

[D716PUWRENCH1]

Liquid Chemical

[D716PUWRENCH1]

Liquid Chemical

[D716PUWRENCH1]

Liquid Chemical

[D716PUWRENCH1]

Liquid Chemical

[D716PUWRENCH1]

Liquid Chemical

[D716PUWRENCH1]

Liquid Chemical

[D716PUWRENCH1]

Liquid Chemical

[D716PUWRENCH1]

Liquid Chemical

[D716PUWRENCH1]

Liquid Chemical

[D716PUWRENCH1]

Liquid Chemical

[D716PUWRENCH1]

Liquid Chemical

[D716PUWRENCH1]

Liquid Chemical

[D716PUWRENCH1]

Liquid Chemical

[D716PUWRENCH1]

Liquid Chemical

[D716PUWRENCH1]

Liquid Chemical

[D716PUWRENCH1]

Liquid Chemical

[D716PUWRENCH1]

Liquid Chemical

[D716PUWRENCH1]

Liquid Chemical

[D716PUWRENCH1]

Liquid Chemical

[D716PUWRENCH1]

Liquid Chemical

[D716PUWRENCH1]

Liquid Chemical

[D716PUWRENCH1]

Liquid Chemical

[D716PUWRENCH1]

Liquid Chemical

[D716PUWRENCH1]

Liquid Chemical

[D716PUWRENCH1]

Liquid Chemical

[D716PUWRENCH1]

Liquid Chemical

[D716PUWRENCH1]

Liquid Chemical

[D716PUWRENCH1]

Liquid Chemical

[D716PUWRENCH1]

Liquid Chemical

[D716PUWRENCH1]

Liquid Chemical

[D716PUWRENCH1]

Liquid Chemical

[D716PUWRENCH1]

Liquid Chemical

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-09
• Device Publish Date: 2022-09-01

On-Brand Devices [ProUltra]

• D716PUWRENCH1: PROULTRA KITS - WRENCH
• D716PUWRENCH011: Proultra Wrench
• D716PULTRAHEX1: ProUltra Hexagon Tip Wrench
• D716PUSURG61: ProUltra Surgical #6 pack
• D716PUSURG51: ProUltra Surgical #5 pack
• D716PUSURG41: ProUltra Surgical #4 pack
• D716PUSURG31: ProUltra Surgical #3 pack
• D716PUSURG21: ProUltra Surgical #2 pack
• D716PUSURG161: ProUltra Surgical 1-6 pack
• D716PUSURG11: ProUltra Surgical #1 pack
• D716PUSINE21: ProUltra SINE Tip #2
• D716PUSINE11: ProUltra SINE Tip #1
• D716PUENDO81: ProUltra Endo Tip #8 pack
• D716PUENDO71: ProUltra Endo Tip #7 pack
• D716PUENDO681: ProUltra Endo Tip 6-8 pack
• D716PUENDO61: ProUltra Endo Tip #6 pack
• D716PUENDO51: ProUltra Endo Tip #5 pack
• D716PUENDO41: ProUltra Endo Tip #4 pack
• D716PUENDO31: ProUltra Endo Tip #3 pack
• D716PUENDO21: ProUltra Endo Tip #2 pack
• D716PUENDO151: ProUltra Endo Tip 1-5 pack
• D716PUENDO11: ProUltra Endo Tip #1 pack