IMRI-SHORT-HD

GUDID 00845384002680

5 cm Heavy Duty Short Attachment. Use with iMRI System Only

Anspach Effort, The

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• Primary Device ID: 00845384002680
• NIH Device Record Key: f4d701cc-efa2-4076-aa3a-8718835392f5
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: IMRI-SHORT-HD
• Catalog Number: IMRI-SHORT-HD
• Company DUNS: 079116867
• Company Name: Anspach Effort, The
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845384002680 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040186

FDA Product Code

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

Sterilization

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

[00845384002680]

Moist Heat or Steam Sterilization

[00845384002680]

Moist Heat or Steam Sterilization

[00845384002680]

Moist Heat or Steam Sterilization

[00845384002680]

Moist Heat or Steam Sterilization

[00845384002680]

Moist Heat or Steam Sterilization

[00845384002680]

Moist Heat or Steam Sterilization

[00845384002680]

Moist Heat or Steam Sterilization

[00845384002680]

Moist Heat or Steam Sterilization

[00845384002680]

Moist Heat or Steam Sterilization

[00845384002680]

Moist Heat or Steam Sterilization

[00845384002680]

Moist Heat or Steam Sterilization

[00845384002680]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-02-05

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• 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