107-022-0060

GUDID 04250869604239

MOSS Ti Rod, Ø5.5x60mm, straight

Biedermann Motech GmbH & Co. KG

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 04250869604239
• NIH Device Record Key: 263c1b78-b733-4fa6-b50f-f80b5522d48d
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 107-022-0060
• Catalog Number: 107-022-0060
• Company DUNS: 320249162
• Company Name: Biedermann Motech GmbH & Co. KG
• 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: false
• 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	04250869604239 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162232

FDA Product Code

• NKB: Thoracolumbosacral pedicle screw system

Sterilization

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

[04250869604239]

Moist Heat or Steam Sterilization

[04250869604239]

Moist Heat or Steam Sterilization

[04250869604239]

Moist Heat or Steam Sterilization

[04250869604239]

Moist Heat or Steam Sterilization

[04250869604239]

Moist Heat or Steam Sterilization

[04250869604239]

Moist Heat or Steam Sterilization

[04250869604239]

Moist Heat or Steam Sterilization

[04250869604239]

Moist Heat or Steam Sterilization

[04250869604239]

Moist Heat or Steam Sterilization

[04250869604239]

Moist Heat or Steam Sterilization

[04250869604239]

Moist Heat or Steam Sterilization

[04250869604239]

Moist Heat or Steam Sterilization

[04250869604239]

Moist Heat or Steam Sterilization

[04250869604239]

Moist Heat or Steam Sterilization

[04250869604239]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-12-17
• Device Publish Date: 2018-11-15

Devices Manufactured by Biedermann Motech GmbH & Co. KG

• 04255772609432 - NA: 2024-08-01 MOSS VRS/MIS Locking Instrument HP
• 04255772609166 - NA: 2024-07-31 MOSS VRS in:situ Ti Reduction Head HP V2
• 04250869635134 - NA: 2024-06-28 DELTA XS Retractor Blade 40mm, straight, medial / lateral
• 04250869636179 - NA: 2024-06-28 MOSS VRS Ti rod, Ø6.0x600mm, straight, hex on both sides, size 4.3
• 04250869654050 - NA: 2024-06-28 MOSS VRS Locking Cap Final Tightener HP, 1/4" coupl., 223mm, ISR27
• 04250869633420 - NA: 2024-06-26 MOSS 100 Caddy Rods
• 04250869654067 - NA: 2024-06-26 MOSS VRS Locking Cap Final Tightener HP, 1/4" coupl., 273mm, ISR27
• 04250869654234 - NA: 2024-06-26 MOSS 100 Ø9.0mm Tap, DL, 1/4" coupling, strengthened, pink