Treace Percuplasty

GUDID 10817417020319

Surgical Motor System W/ VARIABLE-SPEED FOOTSWITCH

ASEPTICO, INC.

Bone/joint surgical power tool motor, electric

• Primary Device ID: 10817417020319
• NIH Device Record Key: 86281b47-b85a-40ac-90e3-36aaa321a2c5
• Commercial Distribution Discontinuation: 2033-08-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Treace Percuplasty
• Version Model Number: AEU-1070TRE-70V
• Company DUNS: 016853348
• Company Name: ASEPTICO, 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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: 4254873157
• Email: regulatory@aseptico.com
• Phone: 4254873157
• Email: regulatory@aseptico.com
• Phone: 4254873157
• Email: regulatory@aseptico.com
• Phone: 4254873157
• Email: regulatory@aseptico.com
• Phone: 4254873157
• Email: regulatory@aseptico.com
• Phone: 4254873157
• Email: regulatory@aseptico.com
• Phone: 4254873157
• Email: regulatory@aseptico.com
• Phone: 4254873157
• Email: regulatory@aseptico.com
• Phone: 4254873157
• Email: regulatory@aseptico.com
• Phone: 4254873157
• Email: regulatory@aseptico.com
• Phone: 4254873157
• Email: regulatory@aseptico.com
• Phone: 4254873157
• Email: regulatory@aseptico.com
• Phone: 4254873157
• Email: regulatory@aseptico.com
• Phone: 4254873157
• Email: regulatory@aseptico.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10817417020319 [Primary]

FDA Product Code

• GEY: Motor, Surgical Instrument, Ac-Powered

Sterilization

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

[10817417020319]

Moist Heat or Steam Sterilization

[10817417020319]

Moist Heat or Steam Sterilization

[10817417020319]

Moist Heat or Steam Sterilization

[10817417020319]

Moist Heat or Steam Sterilization

[10817417020319]

Moist Heat or Steam Sterilization

[10817417020319]

Moist Heat or Steam Sterilization

[10817417020319]

Moist Heat or Steam Sterilization

[10817417020319]

Moist Heat or Steam Sterilization

[10817417020319]

Moist Heat or Steam Sterilization

[10817417020319]

Moist Heat or Steam Sterilization

[10817417020319]

Moist Heat or Steam Sterilization

[10817417020319]

Moist Heat or Steam Sterilization

[10817417020319]

Moist Heat or Steam Sterilization

[10817417020319]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-04
• Device Publish Date: 2025-08-27

Devices Manufactured by ASEPTICO, INC.

• 10817417020319 - Treace Percuplasty: 2025-09-04Surgical Motor System W/ VARIABLE-SPEED FOOTSWITCH
• 10817417020319 - Treace Percuplasty: 2025-09-04 Surgical Motor System W/ VARIABLE-SPEED FOOTSWITCH
• 10817417022313 - Aseptico: 2024-09-26 AEU-350S GO ULTRA PORTABLE DENTAL SYSTEM W/ SCALER
• 10817417020203 - Aseptico: 2023-05-11 Portable Dental Lamp
• 10817417020210 - Aseptico: 2023-05-11 Portable Dental Lamp
• 10817417020111 - Aseptico: 2023-03-27 Dental Implant Motor System
• 10817417020128 - Aseptico: 2023-03-27 Dental Implant Motor System
• 10817417020142 - Aseptico: 2023-03-27 Dental Implant Motor System
• 10817417020159 - Aseptico: 2023-03-27 Dental Implant Motor System