SABLE - Hygienist Package

GUDID 00841359060068

SABLE Standard Latch E-Type Hygienist Package. Package contains: Air Motor(1600110), 4:1 Contra Angle(1600202), Standard Latch Head(1600403)

Sable Industries Inc

Dental power tool handpiece motorless component Dental power tool handpiece motorless component Dental power tool handpiece motorless component Dental power tool handpiece motorless component Dental power tool handpiece motorless component Dental power tool handpiece motorless component Dental power tool handpiece motorless component Dental power tool handpiece motorless component Dental power tool handpiece motorless component Dental power tool handpiece motorless component Dental power tool handpiece motorless component

• Primary Device ID: 00841359060068
• NIH Device Record Key: ed04e1b2-7b5d-499e-84c6-ae27a8567445
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SABLE - Hygienist Package
• Version Model Number: 1600013
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841359060068 [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

[00841359060068]

Moist Heat or Steam Sterilization

[00841359060068]

Moist Heat or Steam Sterilization

[00841359060068]

Moist Heat or Steam Sterilization

[00841359060068]

Moist Heat or Steam Sterilization

[00841359060068]

Moist Heat or Steam Sterilization

[00841359060068]

Moist Heat or Steam Sterilization

[00841359060068]

Moist Heat or Steam Sterilization

[00841359060068]

Moist Heat or Steam Sterilization

[00841359060068]

Moist Heat or Steam Sterilization

[00841359060068]

Moist Heat or Steam Sterilization

[00841359060068]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-08
• Device Publish Date: 2022-07-29

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