GEM BiPolar Bayonet Forceps 521440501010

GUDID 00844735006070

Reusable bipolar forceps designed to function as active electrodes or as accessories to active electrodes.

SYNOVIS MICRO COMPANIES ALLIANCE, INC

Open-surgery electrosurgical handpiece/electrode, bipolar, reusable Open-surgery electrosurgical handpiece/electrode, bipolar, reusable Open-surgery electrosurgical handpiece/electrode, bipolar, reusable Open-surgery electrosurgical handpiece/electrode, bipolar, reusable Open-surgery electrosurgical handpiece/electrode, bipolar, reusable Open-surgery electrosurgical handpiece/electrode, bipolar, reusable Open-surgery electrosurgical handpiece/electrode, bipolar, reusable Open-surgery electrosurgical handpiece/electrode, bipolar, reusable Open-surgery electrosurgical handpiece/electrode, bipolar, reusable Open-surgery electrosurgical handpiece/electrode, bipolar, reusable Open-surgery electrosurgical handpiece/electrode, bipolar, reusable Open-surgery electrosurgical handpiece/electrode, bipolar, reusable Open-surgery electrosurgical handpiece/electrode, bipolar, reusable Open-surgery electrosurgical handpiece/electrode, bipolar, reusable Open-surgery electrosurgical handpiece/electrode, bipolar, reusable Open-surgery electrosurgical handpiece/electrode, bipolar, reusable Open-surgery electrosurgical handpiece/electrode, bipolar, reusable Open-surgery electrosurgical handpiece/electrode, bipolar, reusable Open-surgery electrosurgical handpiece/electrode, bipolar, reusable Open-surgery electrosurgical handpiece/electrode, bipolar, reusable Open-surgery electrosurgical handpiece/electrode, bipolar, reusable Open-surgery electrosurgical handpiece/electrode, bipolar, reusable Open-surgery electrosurgical handpiece/electrode, bipolar, reusable Open-surgery electrosurgical handpiece/electrode, bipolar, reusable Open-surgery electrosurgical handpiece/electrode, bipolar, reusable Open-surgery electrosurgical handpiece/electrode, bipolar, reusable Open-surgery electrosurgical handpiece/electrode, bipolar, reusable Open-surgery electrosurgical handpiece/electrode, bipolar, reusable Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

• Primary Device ID: 00844735006070
• NIH Device Record Key: ca606a04-32cd-4757-9e09-f524c79aa8df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GEM BiPolar Bayonet Forceps
• Version Model Number: GEM4050B-NS
• Catalog Number: 521440501010
• Company DUNS: 031284586
• Company Name: SYNOVIS MICRO COMPANIES ALLIANCE, 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: true
• 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: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Must be stored individually in a protective container in a clean, dry, moisture free area with suitable protection from extreme temperature and humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844735006070 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130669

FDA Product Code

• GEI: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Sterilization

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

[00844735006070]

Moist Heat or Steam Sterilization

[00844735006070]

Moist Heat or Steam Sterilization

[00844735006070]

Moist Heat or Steam Sterilization

[00844735006070]

Moist Heat or Steam Sterilization

[00844735006070]

Moist Heat or Steam Sterilization

[00844735006070]

Moist Heat or Steam Sterilization

[00844735006070]

Moist Heat or Steam Sterilization

[00844735006070]

Moist Heat or Steam Sterilization

[00844735006070]

Moist Heat or Steam Sterilization

[00844735006070]

Moist Heat or Steam Sterilization

[00844735006070]

Moist Heat or Steam Sterilization

[00844735006070]

Moist Heat or Steam Sterilization

[00844735006070]

Moist Heat or Steam Sterilization

[00844735006070]

Moist Heat or Steam Sterilization

[00844735006070]

Moist Heat or Steam Sterilization

[00844735006070]

Moist Heat or Steam Sterilization

[00844735006070]

Moist Heat or Steam Sterilization

[00844735006070]

Moist Heat or Steam Sterilization

[00844735006070]

Moist Heat or Steam Sterilization

[00844735006070]

Moist Heat or Steam Sterilization

[00844735006070]

Moist Heat or Steam Sterilization

[00844735006070]

Moist Heat or Steam Sterilization

[00844735006070]

Moist Heat or Steam Sterilization

[00844735006070]

Moist Heat or Steam Sterilization

[00844735006070]

Moist Heat or Steam Sterilization

[00844735006070]

Moist Heat or Steam Sterilization

[00844735006070]

Moist Heat or Steam Sterilization

[00844735006070]

Moist Heat or Steam Sterilization

[00844735006070]

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: 2016-09-24

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