EG1™ High Speed System XL-HD-G1

GUDID 00845384016526

20.2 cm Heavy Duty X-Long Attachment, G1

Anspach Effort, The

Burring power tool attachment

• Primary Device ID: 00845384016526
• NIH Device Record Key: 48e46ab7-790e-4f70-b1ff-a1f0e02a5827
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EG1™ High Speed System
• Version Model Number: XL-HD-G1
• Catalog Number: XL-HD-G1
• Company DUNS: 079116867
• Company Name: Anspach Effort, The
• 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: 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)327-6887
• Email: ra-dpyus-csvincomfax@its.jnj.com
• Phone: +1(800)327-6887
• Email: ra-dpyus-csvincomfax@its.jnj.com
• Phone: +1(800)327-6887
• Email: ra-dpyus-csvincomfax@its.jnj.com
• Phone: +1(800)327-6887
• Email: ra-dpyus-csvincomfax@its.jnj.com
• Phone: +1(800)327-6887
• Email: ra-dpyus-csvincomfax@its.jnj.com
• Phone: +1(800)327-6887
• Email: ra-dpyus-csvincomfax@its.jnj.com
• Phone: +1(800)327-6887
• Email: ra-dpyus-csvincomfax@its.jnj.com
• Phone: +1(800)327-6887
• Email: ra-dpyus-csvincomfax@its.jnj.com
• Phone: +1(800)327-6887
• Email: ra-dpyus-csvincomfax@its.jnj.com
• Phone: +1(800)327-6887
• Email: ra-dpyus-csvincomfax@its.jnj.com
• Phone: +1(800)327-6887
• Email: ra-dpyus-csvincomfax@its.jnj.com
• Phone: +1(800)327-6887
• Email: ra-dpyus-csvincomfax@its.jnj.com
• Phone: +1(800)327-6887
• Email: ra-dpyus-csvincomfax@its.jnj.com
• Phone: +1(800)327-6887
• Email: ra-dpyus-csvincomfax@its.jnj.com
• Phone: +1(800)327-6887
• Email: ra-dpyus-csvincomfax@its.jnj.com
• Phone: +1(800)327-6887
• Email: ra-dpyus-csvincomfax@its.jnj.com
• Phone: +1(800)327-6887
• Email: ra-dpyus-csvincomfax@its.jnj.com
• Phone: +1(800)327-6887
• Email: ra-dpyus-csvincomfax@its.jnj.com
• Phone: +1(800)327-6887
• Email: ra-dpyus-csvincomfax@its.jnj.com
• Phone: +1(800)327-6887
• Email: ra-dpyus-csvincomfax@its.jnj.com
• Phone: +1(800)327-6887
• Email: ra-dpyus-csvincomfax@its.jnj.com
• Phone: +1(800)327-6887
• Email: ra-dpyus-csvincomfax@its.jnj.com
• Phone: +1(800)327-6887
• Email: ra-dpyus-csvincomfax@its.jnj.com
• Phone: +1(800)327-6887
• Email: ra-dpyus-csvincomfax@its.jnj.com
• Phone: +1(800)327-6887
• Email: ra-dpyus-csvincomfax@its.jnj.com
• Phone: +1(800)327-6887
• Email: ra-dpyus-csvincomfax@its.jnj.com
• Phone: +1(800)327-6887
• Email: ra-dpyus-csvincomfax@its.jnj.com
• Phone: +1(800)327-6887
• Email: ra-dpyus-csvincomfax@its.jnj.com
• Phone: +1(800)327-6887
• Email: ra-dpyus-csvincomfax@its.jnj.com
• Phone: +1(800)327-6887
• Email: ra-dpyus-csvincomfax@its.jnj.com
• Phone: +1(800)327-6887
• Email: ra-dpyus-csvincomfax@its.jnj.com
• Phone: +1(800)327-6887
• Email: ra-dpyus-csvincomfax@its.jnj.com
• Phone: +1(800)327-6887
• Email: ra-dpyus-csvincomfax@its.jnj.com
• Phone: +1(800)327-6887
• Email: ra-dpyus-csvincomfax@its.jnj.com
• Phone: +1(800)327-6887
• Email: ra-dpyus-csvincomfax@its.jnj.com
• Phone: +1(800)327-6887
• Email: ra-dpyus-csvincomfax@its.jnj.com
• Phone: +1(800)327-6887
• Email: ra-dpyus-csvincomfax@its.jnj.com
• Phone: +1(800)327-6887
• Email: ra-dpyus-csvincomfax@its.jnj.com
• Phone: +1(800)327-6887
• Email: ra-dpyus-csvincomfax@its.jnj.com
• Phone: +1(800)327-6887
• Email: ra-dpyus-csvincomfax@its.jnj.com
• Phone: +1(800)327-6887
• Email: ra-dpyus-csvincomfax@its.jnj.com
• Phone: +1(800)327-6887
• Email: ra-dpyus-csvincomfax@its.jnj.com
• Phone: +1(800)327-6887
• Email: ra-dpyus-csvincomfax@its.jnj.com
• Phone: +1(800)327-6887
• Email: ra-dpyus-csvincomfax@its.jnj.com
• Phone: +1(800)327-6887
• Email: ra-dpyus-csvincomfax@its.jnj.com
• Phone: +1(800)327-6887
• Email: ra-dpyus-csvincomfax@its.jnj.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845384016526 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133604

FDA Product Code

• ERL: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Sterilization

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

[00845384016526]

Moist Heat or Steam Sterilization

[00845384016526]

Moist Heat or Steam Sterilization

[00845384016526]

Moist Heat or Steam Sterilization

[00845384016526]

Moist Heat or Steam Sterilization

[00845384016526]

Moist Heat or Steam Sterilization

[00845384016526]

Moist Heat or Steam Sterilization

[00845384016526]

Moist Heat or Steam Sterilization

[00845384016526]

Moist Heat or Steam Sterilization

[00845384016526]

Moist Heat or Steam Sterilization

[00845384016526]

Moist Heat or Steam Sterilization

[00845384016526]

Moist Heat or Steam Sterilization

[00845384016526]

Moist Heat or Steam Sterilization

[00845384016526]

Moist Heat or Steam Sterilization

[00845384016526]

Moist Heat or Steam Sterilization

[00845384016526]

Moist Heat or Steam Sterilization

[00845384016526]

Moist Heat or Steam Sterilization

[00845384016526]

Moist Heat or Steam Sterilization

[00845384016526]

Moist Heat or Steam Sterilization

[00845384016526]

Moist Heat or Steam Sterilization

[00845384016526]

Moist Heat or Steam Sterilization

[00845384016526]

Moist Heat or Steam Sterilization

[00845384016526]

Moist Heat or Steam Sterilization

[00845384016526]

Moist Heat or Steam Sterilization

[00845384016526]

Moist Heat or Steam Sterilization

[00845384016526]

Moist Heat or Steam Sterilization

[00845384016526]

Moist Heat or Steam Sterilization

[00845384016526]

Moist Heat or Steam Sterilization

[00845384016526]

Moist Heat or Steam Sterilization

[00845384016526]

Moist Heat or Steam Sterilization

[00845384016526]

Moist Heat or Steam Sterilization

[00845384016526]

Moist Heat or Steam Sterilization

[00845384016526]

Moist Heat or Steam Sterilization

[00845384016526]

Moist Heat or Steam Sterilization

[00845384016526]

Moist Heat or Steam Sterilization

[00845384016526]

Moist Heat or Steam Sterilization

[00845384016526]

Moist Heat or Steam Sterilization

[00845384016526]

Moist Heat or Steam Sterilization

[00845384016526]

Moist Heat or Steam Sterilization

[00845384016526]

Moist Heat or Steam Sterilization

[00845384016526]

Moist Heat or Steam Sterilization

[00845384016526]

Moist Heat or Steam Sterilization

[00845384016526]

Moist Heat or Steam Sterilization

[00845384016526]

Moist Heat or Steam Sterilization

[00845384016526]

Moist Heat or Steam Sterilization

[00845384016526]

Moist Heat or Steam Sterilization

[00845384016526]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-13
• Device Publish Date: 2021-05-05

Devices Manufactured by Anspach Effort, The

• 00845384018759 - EG1™: 2022-07-18 Wireless Hand Control, EG1A
• 00845384018766 - EG1™: 2022-07-18 Receiver for Wireless Hand Control, EG1A
• 00845384016526 - EG1™ High Speed System: 2021-05-1320.2 cm Heavy Duty X-Long Attachment, G1
• 00845384016526 - EG1™ High Speed System: 2021-05-13 20.2 cm Heavy Duty X-Long Attachment, G1
• 00845384018520 - KINCISE™: 2020-05-06 KINCISE AUTOMATED SURGICAL IMPACTOR
• 00845384018537 - KINCISE™: 2020-05-06 KINCISE RECHARGEABLE LI-ION BATTERY
• 00845384018544 - KINCISE™: 2020-05-06 KINCISE 4-PORT BATTERY CHARGER
• 00845384018551 - KINCISE™: 2020-05-06 KINCISE POSTERIOR BROACH ADAPTER
• 00845384018568 - KINCISE™: 2020-05-06 KINCISE ANTERIOR BROACH ADAPTER