XMAX

GUDID 00845384010791

XMax Handpiece

Anspach Effort, The

Multi-purpose surgical power tool system, pneumatic Bone/joint surgical power tool motorized handpiece/set, electric, reusable Bone/joint surgical power tool motorized handpiece/set, electric, reusable Bone/joint surgical power tool motorized handpiece/set, electric, reusable Bone/joint surgical power tool motorized handpiece/set, electric, reusable Bone/joint surgical power tool motorized handpiece/set, electric, reusable Bone/joint surgical power tool motorized handpiece/set, electric, reusable Bone/joint surgical power tool motorized handpiece/set, electric, reusable Bone/joint surgical power tool motorized handpiece/set, electric, reusable Bone/joint surgical power tool motorized handpiece/set, electric, reusable Bone/joint surgical power tool motorized handpiece/set, electric, reusable Bone/joint surgical power tool motorized handpiece/set, electric, reusable Bone/joint surgical power tool motorized handpiece/set, electric, reusable Bone/joint surgical power tool motorized handpiece/set, electric, reusable Bone/joint surgical power tool motorized handpiece/set, electric, reusable Bone/joint surgical power tool motorized handpiece/set, electric, reusable Bone/joint surgical power tool motorized handpiece/set, electric, reusable Bone/joint surgical power tool motorized handpiece/set, electric, reusable Bone/joint surgical power tool motorized handpiece/set, electric, reusable

• Primary Device ID: 00845384010791
• NIH Device Record Key: a1821846-247a-4e38-8092-4f187664df45
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: XMAX
• Catalog Number: XMAX
• 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)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com
• Phone: +1(800)255-2500
• Email: RA-DPYNA-anspachpowe@its.jnj.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845384010791 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K965080

FDA Product Code

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

Sterilization

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

[00845384010791]

Moist Heat or Steam Sterilization

[00845384010791]

Moist Heat or Steam Sterilization

[00845384010791]

Moist Heat or Steam Sterilization

[00845384010791]

Moist Heat or Steam Sterilization

[00845384010791]

Moist Heat or Steam Sterilization

[00845384010791]

Moist Heat or Steam Sterilization

[00845384010791]

Moist Heat or Steam Sterilization

[00845384010791]

Moist Heat or Steam Sterilization

[00845384010791]

Moist Heat or Steam Sterilization

[00845384010791]

Moist Heat or Steam Sterilization

[00845384010791]

Moist Heat or Steam Sterilization

[00845384010791]

Moist Heat or Steam Sterilization

[00845384010791]

Moist Heat or Steam Sterilization

[00845384010791]

Moist Heat or Steam Sterilization

[00845384010791]

Moist Heat or Steam Sterilization

[00845384010791]

Moist Heat or Steam Sterilization

[00845384010791]

Moist Heat or Steam Sterilization

[00845384010791]

Moist Heat or Steam Sterilization

[00845384010791]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-22
• Device Publish Date: 2018-02-05

Devices Manufactured by Anspach Effort, The

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• 00845384018766 - EG1™: 2022-07-18 Receiver for Wireless Hand Control, EG1A
• 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