Classic Stepper H40342LL

GUDID 00841436108768

For use with GE Healthcare ERB transducers

CIVCO MEDICAL INSTRUMENTS CO., INC.

Nonimplantable needle guide, single-use

• Primary Device ID: 00841436108768
• NIH Device Record Key: d7fb1ffa-a5e8-4873-8b3b-02e7fcdddaa7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Classic Stepper
• Version Model Number: H40342LL
• Catalog Number: H40342LL
• Company DUNS: 134614411
• Company Name: CIVCO MEDICAL INSTRUMENTS CO., INC.
• Device Count: 20
• 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: true
• Serial Number: true
• Manufacturing Date: true
• 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(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com

Device Dimensions

• Height: 1.3 Inch
• Length: 7.1 Inch
• Height: 1.3 Inch
• Length: 7.1 Inch
• Height: 1.3 Inch
• Length: 7.1 Inch
• Height: 1.3 Inch
• Length: 7.1 Inch
• Height: 1.3 Inch
• Length: 7.1 Inch
• Height: 1.3 Inch
• Length: 7.1 Inch
• Height: 1.3 Inch
• Length: 7.1 Inch
• Height: 1.3 Inch
• Length: 7.1 Inch
• Height: 1.3 Inch
• Length: 7.1 Inch
• Height: 1.3 Inch
• Length: 7.1 Inch
• Height: 1.3 Inch
• Length: 7.1 Inch
• Height: 1.3 Inch
• Length: 7.1 Inch
• Height: 1.3 Inch
• Length: 7.1 Inch
• Height: 1.3 Inch
• Length: 7.1 Inch
• Height: 1.3 Inch
• Length: 7.1 Inch
• Height: 1.3 Inch
• Length: 7.1 Inch
• Height: 1.3 Inch
• Length: 7.1 Inch
• Height: 1.3 Inch
• Length: 7.1 Inch
• Height: 1.3 Inch
• Length: 7.1 Inch
• Height: 1.3 Inch
• Length: 7.1 Inch
• Height: 1.3 Inch
• Length: 7.1 Inch
• Height: 1.3 Inch
• Length: 7.1 Inch
• Height: 1.3 Inch
• Length: 7.1 Inch
• Height: 1.3 Inch
• Length: 7.1 Inch
• Height: 1.3 Inch
• Length: 7.1 Inch
• Height: 1.3 Inch
• Length: 7.1 Inch
• Height: 1.3 Inch
• Length: 7.1 Inch
• Height: 1.3 Inch
• Length: 7.1 Inch
• Height: 1.3 Inch
• Length: 7.1 Inch
• Height: 1.3 Inch
• Length: 7.1 Inch
• Height: 1.3 Inch
• Length: 7.1 Inch
• Height: 1.3 Inch
• Length: 7.1 Inch
• Height: 1.3 Inch
• Length: 7.1 Inch
• Height: 1.3 Inch
• Length: 7.1 Inch
• Height: 1.3 Inch
• Length: 7.1 Inch
• Height: 1.3 Inch
• Length: 7.1 Inch
• Height: 1.3 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841436108768 [Primary]
GS1	80841436108764 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970514

FDA Product Code

• ITX: Transducer, ultrasonic, diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-07
• Device Publish Date: 2017-08-22

On-Brand Devices [Classic Stepper]

• 00841436108768: For use with GE Healthcare ERB transducers
• 00841436111454: For use with Esaote TRT33 transducers
• 00841436107266: For use with Siemens Endo-PII transducers
• 00841436105835: For use with Hitachi Aloka Medical C41L47RP and EUP-U533 transducers
• 00841436105774: For use with GE Healthcare ERB transducers
• 00841436105262: For use with BK Medical 8658(8558), 8848 and E14CL4b transducers
• 00841436105101: For use with Hitachi Aloka Medical UST-672-5/7.5 transducers
• 00841436101233: For use with Best® Sonalis™ TRT TriView transducers
• 00841436121101: For use with GE E7CBL transducers