HEARTLINE CRILEWOOD NEEDLE HOLDER

GUDID B0992800050L0

HEARTLINE CRILEWOOD NEEDLE HOLDER WITH LOCK TUNGSTEN CARBIDE STRAIGHT JAW SQUEEZE HANDLE

SONTEC INSTRUMENTS, INC.

Needle holder, reusable Needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable

• Primary Device ID: B0992800050L0
• NIH Device Record Key: 85e183c9-fa2c-4c75-8a11-5af2f93a91ab
• Commercial Distribution Discontinuation: 2018-06-22
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: HEARTLINE CRILEWOOD NEEDLE HOLDER
• Version Model Number: 2800-050L
• Company DUNS: 040729840
• Company Name: SONTEC INSTRUMENTS, INC.
• 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: true
• Serial Number: false
• 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: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com

Device Dimensions

• Length: 28.7 Centimeter
• Device Size Text, specify: 0
• Length: 28.7 Centimeter
• Device Size Text, specify: 0
• Length: 28.7 Centimeter
• Device Size Text, specify: 0
• Length: 28.7 Centimeter
• Device Size Text, specify: 0
• Length: 28.7 Centimeter
• Device Size Text, specify: 0
• Length: 28.7 Centimeter
• Device Size Text, specify: 0
• Length: 28.7 Centimeter
• Device Size Text, specify: 0
• Length: 28.7 Centimeter
• Device Size Text, specify: 0
• Length: 28.7 Centimeter
• Device Size Text, specify: 0
• Length: 28.7 Centimeter
• Device Size Text, specify: 0
• Length: 28.7 Centimeter
• Device Size Text, specify: 0
• Length: 28.7 Centimeter
• Device Size Text, specify: 0
• Length: 28.7 Centimeter
• Device Size Text, specify: 0
• Length: 28.7 Centimeter
• Device Size Text, specify: 0
• Length: 28.7 Centimeter
• Device Size Text, specify: 0
• Length: 28.7 Centimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B0992800050L0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152400

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

[B0992800050L0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992800050L0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992800050L0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992800050L0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992800050L0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992800050L0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992800050L0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992800050L0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992800050L0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992800050L0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992800050L0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992800050L0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992800050L0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992800050L0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992800050L0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992800050L0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-19

On-Brand Devices [HEARTLINE CRILEWOOD NEEDLE HOLDER]

• B0992800050S0: HEARTLINE CRILEWOOD NEEDLE HOLDER WITH LOCK TUNGSTEN CARBIDE STRAIGHT JAW SQUEEZE HANDLE
• B09928000500: HEARTLINE CRILEWOOD NEEDLE HOLDER WITH LOCK TUNGSTEN CARBIDE STRAIGHT JAW SQUEEZE HANDLE
• B0992800010S0: HEARTLINE CRILEWOOD NEEDLE HOLDER WITH LOCK TUNGSTEN CARBIDE CURVED JAW SQUEEZE HANDLE
• B0992800010L0: HEARTLINE CRILEWOOD NEEDLE HOLDER WITH LOCK TUNGSTEN CARBIDE CURVED JAW SQUEEZE HANDLE
• B09928000100: HEARTLINE CRILEWOOD NEEDLE HOLDER WITH LOCK TUNGSTEN CARBIDE CURVED JAW SQUEEZE HANDLE
• B0992800050L0: HEARTLINE CRILEWOOD NEEDLE HOLDER WITH LOCK TUNGSTEN CARBIDE STRAIGHT JAW SQUEEZE HANDLE