M-35SDC

GUDID 00845384003922

3.5 mm Coarse Diamond Ball, Standard Length. Use with MEDIUM Attachment.

Anspach Effort, The

Cranial bur, single-use

• Primary Device ID: 00845384003922
• NIH Device Record Key: d75954fc-6d97-4a38-a114-ba74b7bbd4ec
• Commercial Distribution Discontinuation: 2023-08-07
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: M-35SDC
• Catalog Number: M-35SDC
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845384003922 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080802

FDA Product Code

• HBE: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-08-14
• Device Publish Date: 2016-09-09

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: 2021-05-13 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