SABLE - Hygienist Package

GUDID 00841359060129

Hygienist One Piece 4:1 Screw-In E-Type Package Package Contains: Air Motor (1600110), Contra Angle (1600216)

Sable Industries Inc

Dental surgical power tool motor, pneumatic

• Primary Device ID: 00841359060129
• NIH Device Record Key: 9b78aa9d-0234-4e4b-9748-6f4e63ba8bae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SABLE - Hygienist Package
• Version Model Number: 1600025
• Company DUNS: 255407272
• Company Name: Sable Industries Inc
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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: 1-800-368-8106
• Email: info@sableindustriesinc.com
• Phone: 1-800-368-8106
• Email: info@sableindustriesinc.com
• Phone: 1-800-368-8106
• Email: info@sableindustriesinc.com
• Phone: 1-800-368-8106
• Email: info@sableindustriesinc.com
• Phone: 1-800-368-8106
• Email: info@sableindustriesinc.com
• Phone: 1-800-368-8106
• Email: info@sableindustriesinc.com
• Phone: 1-800-368-8106
• Email: info@sableindustriesinc.com
• Phone: 1-800-368-8106
• Email: info@sableindustriesinc.com
• Phone: 1-800-368-8106
• Email: info@sableindustriesinc.com
• Phone: 1-800-368-8106
• Email: info@sableindustriesinc.com
• Phone: 1-800-368-8106
• Email: info@sableindustriesinc.com
• Phone: 1-800-368-8106
• Email: info@sableindustriesinc.com
• Phone: 1-800-368-8106
• Email: info@sableindustriesinc.com
• Phone: 1-800-368-8106
• Email: info@sableindustriesinc.com
• Phone: 1-800-368-8106
• Email: info@sableindustriesinc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841359060129 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083101

FDA Product Code

• EGS: Handpiece, Contra- And Right-Angle Attachment, Dental

Sterilization

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

[00841359060129]

Moist Heat or Steam Sterilization

[00841359060129]

Moist Heat or Steam Sterilization

[00841359060129]

Moist Heat or Steam Sterilization

[00841359060129]

Moist Heat or Steam Sterilization

[00841359060129]

Moist Heat or Steam Sterilization

[00841359060129]

Moist Heat or Steam Sterilization

[00841359060129]

Moist Heat or Steam Sterilization

[00841359060129]

Moist Heat or Steam Sterilization

[00841359060129]

Moist Heat or Steam Sterilization

[00841359060129]

Moist Heat or Steam Sterilization

[00841359060129]

Moist Heat or Steam Sterilization

[00841359060129]

Moist Heat or Steam Sterilization

[00841359060129]

Moist Heat or Steam Sterilization

[00841359060129]

Moist Heat or Steam Sterilization

[00841359060129]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-06
• Device Publish Date: 2022-09-28

On-Brand Devices [SABLE - Hygienist Package]

• 00841359060099: SABLE Ball Bearing Screw In E-Type Hygienist Package. Package contains: Air Motor(1600110), 4:1
• 00841359060075: SABLE Ball Bearing Swing Latch E-Type Hygienist Package. Package contains: Air Motor(1600110), 4
• 00841359060068: SABLE Standard Latch E-Type Hygienist Package. Package contains: Air Motor(1600110), 4:1 Contra
• 00841359060051: SABLE Screw-In E-Type Hygienist Package. Package contains: Air Motor(1600110), 4:1 Contra Angle(
• 00841359060044: SABLE Snap-On E-Type Hygienist Package. Package Contains: Air Motor(1600110), 4:1 Contra Angle(1
• 00841359060136: Hygienist One Piece 4:1 Push Button Latch E-Type Package Package Contains: Air Motor (1600110),
• 00841359060129: Hygienist One Piece 4:1 Screw-In E-Type Package Package Contains: Air Motor (1600110), Contra A