HEARTLINE MAYO HEGAR NEEDLE HOLDER

GUDID B0992800061S0

HEARTLINE MAYO HEGAR NEEDLE HOLDER HEAVY WITH LOCK TUNGSTEN CARBIDE JAW CURVED

SONTEC INSTRUMENTS, INC.

Needle holder, reusable

• Primary Device ID: B0992800061S0
• NIH Device Record Key: 26e10b99-b3a5-4322-b4bb-da2a773f7c5a
• Commercial Distribution Discontinuation: 2018-06-22
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: HEARTLINE MAYO HEGAR NEEDLE HOLDER
• Version Model Number: 2800-061S
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 18008217496
• Email: info@sontecinstruments.com
• Phone: 18008217496
• Email: info@sontecinstruments.com
• Phone: 18008217496
• Email: info@sontecinstruments.com
• Phone: 18008217496
• Email: info@sontecinstruments.com
• Phone: 18008217496
• Email: info@sontecinstruments.com
• Phone: 18008217496
• Email: info@sontecinstruments.com
• Phone: 18008217496
• Email: info@sontecinstruments.com
• Phone: 18008217496
• Email: info@sontecinstruments.com
• Phone: 18008217496
• Email: info@sontecinstruments.com
• Phone: 18008217496
• Email: info@sontecinstruments.com
• Phone: 18008217496
• Email: info@sontecinstruments.com
• Phone: 18008217496
• Email: info@sontecinstruments.com
• Phone: 18008217496
• Email: info@sontecinstruments.com
• Phone: 18008217496
• Email: info@sontecinstruments.com
• Phone: 18008217496
• Email: info@sontecinstruments.com
• Phone: 18008217496
• Email: info@sontecinstruments.com

Device Dimensions

• Length: 17.8 Centimeter
• Device Size Text, specify: 0
• Length: 17.8 Centimeter
• Device Size Text, specify: 0
• Length: 17.8 Centimeter
• Device Size Text, specify: 0
• Length: 17.8 Centimeter
• Device Size Text, specify: 0
• Length: 17.8 Centimeter
• Device Size Text, specify: 0
• Length: 17.8 Centimeter
• Device Size Text, specify: 0
• Length: 17.8 Centimeter
• Device Size Text, specify: 0
• Length: 17.8 Centimeter
• Device Size Text, specify: 0
• Length: 17.8 Centimeter
• Device Size Text, specify: 0
• Length: 17.8 Centimeter
• Device Size Text, specify: 0
• Length: 17.8 Centimeter
• Device Size Text, specify: 0
• Length: 17.8 Centimeter
• Device Size Text, specify: 0
• Length: 17.8 Centimeter
• Device Size Text, specify: 0
• Length: 17.8 Centimeter
• Device Size Text, specify: 0
• Length: 17.8 Centimeter
• Device Size Text, specify: 0
• Length: 17.8 Centimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B0992800061S0 [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

[B0992800061S0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992800061S0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992800061S0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992800061S0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992800061S0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992800061S0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992800061S0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992800061S0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992800061S0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992800061S0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992800061S0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992800061S0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992800061S0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992800061S0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992800061S0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992800061S0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-16

On-Brand Devices [HEARTLINE MAYO HEGAR NEEDLE HOLDER]

• 00192896092228: HEARTLINE MAYO HEGAR NEEDLE HOLDER WITH LOCK CURVED TUNGSTEN CARBIDE TIP HEAVY
• B0992800061L0: HEARTLINE MAYO HEGAR NEEDLE HOLDER HEAVY WITH LOCK TUNGSTEN CARBIDE JAW CURVED
• B09928000610: HEARTLINE MAYO HEGAR NEEDLE HOLDER HEAVY WITH LOCK TUNGSTEN CARBIDE JAW CURVED
• B0992800060L0: HEARTLINE MAYO HEGAR NEEDLE HOLDER HEAVY WITH LOCK TUNGSTEN CARBIDE JAW STRAIGHT
• B09928000600: HEARTLINE MAYO HEGAR NEEDLE HOLDER WITH LOCK HEAVY TUNGSTEN CARBIDE JAW STRAIGHT
• B0992800061S0: HEARTLINE MAYO HEGAR NEEDLE HOLDER HEAVY WITH LOCK TUNGSTEN CARBIDE JAW CURVED
• 00192896094420: HEARTLINE MAYO HEGAR NEEDLE HOLDER WITH LOCK STRAIGHT TUNGSTEN CARBIDE TIP HEAVY