Sternal Cable System

GUDID 10841291105831

SS REVERSE CUTTING NEEDLE, 1 CABLE PER POUCH

A & E MEDICAL CORPORATION

Sternal fixation device

• Primary Device ID: 10841291105831
• NIH Device Record Key: ad4a76b6-a02b-4acc-aa27-d130b987c6df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sternal Cable System
• Version Model Number: 400-413
• Company DUNS: 173770868
• Company Name: A & E MEDICAL CORPORATION
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841291105831 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193479

FDA Product Code

• JDQ: Cerclage, Fixation

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: 2025-04-29
• Device Publish Date: 2025-04-21

On-Brand Devices [Sternal Cable System]

• 10841291106081: INSTRUMENT CASE
• 10841291106043: Ti TWO PACK STERNAL CRIMPS
• 10841291106036: Ti TAPERED BLUNT NEEDLE, 4 CABLES PER POUCH
• 10841291106029: Ti REVERSE CUTTING NEEDLE, 4 CABLES PER POUCH
• 10841291106012: Ti 3 TAPERED BLUNT & 1 CUTTING EDGE NEEDLE, 4 CABLES PER POUCH
• 10841291106005: Ti TAPERED CUTTING NEEDLE, 4 CABLES PER POUCH
• 10841291105992: CRIMPER/TENSIONER
• 10841291105978: SS TAPERED BLUNT NEEDLE, 4 CABLES PER POUCH
• 10841291105961: SS 3 TAPERED BLUNT & 1 CUTTING EDGE NEEDLE, 4 CABLES PER POUCH
• 10841291105954: SS TAPERED BLUNT NEEDLE, 1 CABLE PER POUCH
• 10841291105947: Ti CUTTING EDGE NEEDLE, 4 CABLES PER POUCH
• 10841291105930: SS 3 TAPERED CUTTING & 1 REVERSE CUTTING NEEDLE, 4 CABLES PER POUCH
• 10841291105923: SS REVERSE CUTTING NEEDLE, 3 CABLES PER POUCH
• 10841291105916: SS CUTTING EDGE NEEDLE, 1 CABLE PER POUCH
• 10841291105909: SS CUTTING EDGE NEEDLE, 3 CABLES PER POUCH
• 10841291105893: SS CUTTING EDGE NEEDLE, 4 CABLES PER POUCH
• 10841291105862: SS TAPERED CUTTING NEEDLE, 1 CABLE PER POUCH
• 10841291105855: SS TAPERED CUTTING NEEDLE, 4 CABLES PER POUCH
• 10841291105831: SS REVERSE CUTTING NEEDLE, 1 CABLE PER POUCH
• 10841291105824: SS REVERSE CUTTING NEEDLE, 4 CABLES PER POUCH
• 10841291105817: CABLE CUTTER
• 10841291105794: SS TWO PACK STERNAL CRIMPS