N/A LF1212A

GUDID 57613327565305

STRYKER SUSTAINABILITY SOLUTIONS, INC.

Open-surgery electrosurgical handpiece/electrode, bipolar, reprocessed

• Primary Device ID: 57613327565305
• NIH Device Record Key: e3328eec-d22a-45be-9925-3bf6a1d9066f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: LF1212A
• Catalog Number: LF1212A
• Company DUNS: 020198912
• Company Name: STRYKER SUSTAINABILITY SOLUTIONS, 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com

Device Dimensions

• Length: 19 Centimeter
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Operating and Storage Conditions

• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327565300 [Primary]
GS1	57613327565305 [Package]; Contains: 07613327565300; Package: case [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220411

FDA Product Code

• NUJ: Electrosurgical, cutting & coagulation accessories, laparoscopic & endoscopic, reprocessed

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-21
• Device Publish Date: 2022-06-10

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• 00885825020903: Restep Pump
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• 00885825020880: Fast FX Strut 195mm to 311mm
• 00885825020859: Large Combination Clamp
• 00885825020842: Straight Post
• 00885825020835: Multi Pin Clamp
• 00885825020828: Angled Post
• 00885825020811: Pin Clamp
• 00885825020804: Rod to Rod Clamp
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• 00885825020767: Carbon Fiber Rod
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• 00885825020668: Adjustable Clamp
• 00885825020651: 30 Degress Outrigger Post
• 00885825020644: Outrigger Post
• 00885825020637: Pin Clamp
• 00885825020620: Pin Clamp
• 00885825020613: Adjustable Clamp
• 00885825020606: Adjustable Clamp
• 00885825020590: Tube to Tube Clamp
• 00885825020583: Multi-Pin Clamp
• 00885825020576: Rod Attachment
• 00885825020569: Multi-Pin Clamp
• 00885825020361: Universal Clamp
• 00885825020354: Universal Clamp
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• 00885825020293: Rod to Rod Clamp
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