N/A 394.89

GUDID 00885825020781

Carbon Fiber Rod

STRYKER SUSTAINABILITY SOLUTIONS, INC.

External orthopaedic fixation system reprocessed component

• Primary Device ID: 00885825020781
• NIH Device Record Key: f428efd5-46f9-46a8-9c5b-e1c8b683eaf7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: N/A
• Catalog Number: 394.89
• Company DUNS: 020198912
• Company Name: STRYKER SUSTAINABILITY SOLUTIONS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: 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(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com

Device Dimensions

• Length: 500 Millimeter
• Length: 500 Millimeter
• Length: 500 Millimeter
• Length: 500 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885825020781 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012623

FDA Product Code

• KTT: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

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

[00885825020781]

Moist Heat or Steam Sterilization

[00885825020781]

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: 2016-09-23

On-Brand Devices [N/A]

• 00885825021030: JET-X Mini Clamp 6mm to 4mm
• 00885825021023: Carbon Rod
• 00885825021016: Carbon Fiber Rod
• 00885825020958: Diagnostic Ultrasound Catheter, 8F
• 00885825020941: Diagnostic Ultrasound Catheter, 10F
• 00885825020927: Diagnostic Ultrasound Catheter, 8F
• 00885825020910: Diagnostic Ultrasound Catheter, 10F
• 00885825020903: Restep Pump
• 30885825020898: Bladeless Trocar w/Stability Sleeve
• 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
• 00885825020798: Carbon Fiber Rod
• 00885825020781: Carbon Fiber Rod
• 00885825020774: Carbon Fiber Rod
• 00885825020767: Carbon Fiber Rod
• 00885825020750: Carbon Fiber Rod
• 00885825020743: Carbon Fiber Rod
• 00885825020736: Carbon Fiber Rod
• 00885825020729: Carbon Fiber Rod
• 00885825020712: Carbon Fiber Rod
• 00885825020705: Carbon Fiber Rod
• 00885825020699: Carbon Fiber Rod
• 00885825020682: Carbon Fiber Rod
• 00885825020675: MonoTube Triax Pin Clamp External Fixation System
• 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
• 00885825020347: Universal Clamp
• 00885825020330: Rod to Rod Clamp
• 00885825020323: Rod to Rod Clamp
• 00885825020316: Rod to Rod Clamp
• 00885825020309: Rod to Rod Clamp
• 00885825020293: Rod to Rod Clamp
• 00885825020286: Carbon Fiber Rod
• 00885825020279: Carbon Fiber Rod