Propel ASM-20010-01

GUDID 00852673007035

Assy. Packaged Disposable Drill Tip, Closed

PROPEL ORTHODONTICS LLC

Surgical drill guide, single-use

• Primary Device ID: 00852673007035
• NIH Device Record Key: 2549c1d4-51bd-4e9a-ae8b-f93d5bd7ee77
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Propel
• Version Model Number: ASM-20010-01
• Catalog Number: ASM-20010-01
• Company DUNS: 117334253
• Company Name: PROPEL ORTHODONTICS 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 408 394 5851
• Email: bw@propelortho.com
• Phone: 408 394 5851
• Email: bw@propelortho.com
• Phone: 408 394 5851
• Email: bw@propelortho.com
• Phone: 408 394 5851
• Email: bw@propelortho.com
• Phone: 408 394 5851
• Email: bw@propelortho.com
• Phone: 408 394 5851
• Email: bw@propelortho.com
• Phone: 408 394 5851
• Email: bw@propelortho.com
• Phone: 408 394 5851
• Email: bw@propelortho.com
• Phone: 408 394 5851
• Email: bw@propelortho.com
• Phone: 408 394 5851
• Email: bw@propelortho.com
• Phone: 408 394 5851
• Email: bw@propelortho.com
• Phone: 408 394 5851
• Email: bw@propelortho.com
• Phone: 408 394 5851
• Email: bw@propelortho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852673007035 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150392

FDA Product Code

• DZJ: Driver, Wire, And Bone Drill, Manual

Sterilization

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

[00852673007035]

Radiation Sterilization

[00852673007035]

Radiation Sterilization

[00852673007035]

Radiation Sterilization

[00852673007035]

Radiation Sterilization

[00852673007035]

Radiation Sterilization

[00852673007035]

Radiation Sterilization

[00852673007035]

Radiation Sterilization

[00852673007035]

Radiation Sterilization

[00852673007035]

Radiation Sterilization

[00852673007035]

Radiation Sterilization

[00852673007035]

Radiation Sterilization

[00852673007035]

Radiation Sterilization

[00852673007035]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-01-23
• Device Publish Date: 2016-12-28

On-Brand Devices [Propel]

• 00852673007097: VPro+
• 00852673007080: C-Shaped Vibration Device, Brazil
• 00852673007073: Packaged C-Shaped Mouthpiece, Tapered, Assy
• 00852673007066: Packaged Mouthpiece, Single, Assy
• 00852673007059: Assy. Packaged Disposable Drill Tip-Open
• 00852673007042: Propel, Reusable Handle
• 00852673007035: Assy. Packaged Disposable Drill Tip, Closed
• 00852673007028: Assy. Packaged Perforation Device, Contra-Angle
• 00852673007011: C-Shaped Vibration Device
• 00852673007004: Perforation Device, Propel XL