Smart Kit Modular OnePedicle 16/16

GUDID 04250203940658

Joline GmbH & Co. KG

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• Primary Device ID: 04250203940658
• NIH Device Record Key: 19711a2c-c5ec-4fa2-840b-1b3ab7d7bf5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smart Kit Modular OnePedicle 16/16
• Version Model Number: US7NN1110
• Company DUNS: 342087108
• Company Name: Joline 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: true
• 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	04250203940658 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192449

FDA Product Code

• HRX: Arthroscope

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: 2020-08-24
• Device Publish Date: 2020-08-14

Devices Manufactured by Joline GmbH & Co. KG

• 04250203940399 - Best Kit Stop'n GO 2 x 8 mm: 2020-08-24
• 04250203940405 - Best Kit Mod. One Pedicle Stop'n GO 2 x 8 mm: 2020-08-24
• 04250203940436 - Best Kit SpeedTrack Stop'n GO 2 x 8 mm: 2020-08-24
• 04250203940443 - Best Kit RapidIntro Bevel Tip Stop'n GO 2 x 8 mm: 2020-08-24
• 04250203940450 - Best Kit Stop'n GO 2 x 8 mm: 2020-08-24
• 04250203940467 - Best Kit SpeedTrack Stop'n GO 2 x 8 mm: 2020-08-24
• 04250203940474 - Best Kit RapidIntro Bevel Tip Stop'n GO 2 x 8 mm: 2020-08-24
• 04250203940481 - Best Kit Mod. One Pedicle Stop'n GO 2 x 8 mm: 2020-08-24