Valkyrie Thoracic Fixation System 01-3515-HA

GUDID 00810071390234

HA Screw, Ø3.5 x 15mm

J.M. Longyear Manufacturing, LLC

Sternal fixation device

• Primary Device ID: 00810071390234
• NIH Device Record Key: 02d5ec60-6942-4d24-8e4a-bbe1fed34839
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Valkyrie Thoracic Fixation System
• Version Model Number: 01-3515-HA
• Catalog Number: 01-3515-HA
• Company DUNS: 081307059
• Company Name: J.M. Longyear Manufacturing, LLC
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810071390234 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202889

FDA Product Code

• HWC: Screw, Fixation, Bone

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: 2021-08-02
• Device Publish Date: 2021-07-23

On-Brand Devices [Valkyrie Thoracic Fixation System]

• 00810071390234: HA Screw, Ø3.5 x 15mm
• 00810071390227: HA Screw, Ø3.0 x 15mm
• 00810071390210: HA Screw, Ø3.0 x 8mm (4-pack)
• 00810071390111: HA Screw, Ø3.0 x 13mm (2-pack)
• 00810071390104: HA Screw, Ø3.0 x 13mm (4-pack)
• 00810071390098: HA Screw, Ø3.0 x 10mm (2-pack)
• 00810071390081: HA Screw, Ø3.0 x 10mm (4-pack)
• 00810071390265: HA Screw, Ø3.0 x 8mm (4-pack)
• 00810071390258: HA Screw, Ø3.0 x 15mm (4-pack)
• 00810071390241: Rectangle Plate
• 00810071390203: HA Screw, Ø3.5 x 13mm
• 00810071390197: HA Screw, Ø3.5 x 10mm
• 00810071390180: HA Screw, Ø3.5 x 8mm
• 00810071390173: HA Screw, Ø3.0 x 13mm
• 00810071390166: HA Screw, Ø3.0 x 10mm
• 00810071390159: HA Screw, Ø3.0 x 8mm
• 00810071390142: Driver Bit, No Shoulder
• 00810071390135: Driver Bit, Short
• 00810071390128: Driver Bit
• 00810071390074: Straight Plate 16-hole
• 00810071390067: Straight Plate 8-hole
• 00810071390050: Ladder Plate
• 00810071390043: Box Plate
• 00810071390036: T-Plate
• 00810071390029: M-Plate
• 00810071390012: X-Plate
• 00810071390005: V-Plate
• 00810071390517: HA Screw, Ø3.0 x 15mm (4-pack), Qty. 4
• 00810071390500: HA Screw, Ø3.0 x 15mm (4-pack), Qty. 2
• 00810071390494: HA Screw, Ø3.0 x 13mm (2-pack), Qty. 3
• 00810071390487: HA Screw, Ø3.0 x 13mm (2-pack), Qty. 2
• 00810071390470: HA Screw, Ø3.0 x 13mm (4-pack), Qty. 4
• 00810071390463: HA Screw, Ø3.0 x 13mm (4-pack), Qty. 2
• 00810071390456: HA Screw, Ø3.0 x 10mm (2-pack), Qty. 3
• 00810071390449: HA Screw, Ø3.0 x 10mm (2-pack), Qty. 2
• 00810071390432: HA Screw, Ø3.0 x 10mm (4-pack), Qty. 4
• 00810071390425: HA Screw, Ø3.0 x 10mm (4-pack), Qty. 2
• 00810071390838: HA Screw, Ø3.0 x 15mm (2-pack), Qty. 3
• 00810071390821: HA Screw, Ø3.0 x 15mm (2-pack), Qty. 2
• 00810071390616: M10 Plate
• 00810071390609: Hex Plate
• 00810071390593: H-Plate
• 00810071390814: HA Screw, Ø3.0 x 15mm (4-pack), Qty. 4
• 00810071390807: HA Screw, Ø3.0 x 15mm (4-pack), Qty. 2
• 00810071390791: HA Screw, Ø3.0 x 13mm (2-pack), Qty. 3
• 00810071390784: HA Screw, Ø3.0 x 13mm (2-pack), Qty. 2
• 00810071390777: HA Screw, Ø3.0 x 13mm (4-pack), Qty. 4
• 00810071390760: HA Screw, Ø3.0 x 13mm (4-pack), Qty. 2
• 00810071390753: HA Screw, Ø3.0 x 10mm (2-pack), Qty. 3
• 00810071390746: HA Screw, Ø3.0 x 10mm (2-pack), Qty. 2