Mixer

GUDID 04250203940917

Joline GmbH & Co. KG

Manual orthopaedic cement mixer, single-use Manual orthopaedic cement mixer, single-use Manual orthopaedic cement mixer, single-use Manual orthopaedic cement mixer, single-use Manual orthopaedic cement mixer, single-use Manual orthopaedic cement mixer, single-use Manual orthopaedic cement mixer, single-use Manual orthopaedic cement mixer, single-use Manual orthopaedic cement mixer, single-use Manual orthopaedic cement mixer, single-use Manual orthopaedic cement mixer, single-use Manual orthopaedic cement mixer, single-use Manual orthopaedic cement mixer, single-use Manual orthopaedic cement mixer, single-use

• Primary Device ID: 04250203940917
• NIH Device Record Key: 919df560-6eaf-40aa-bf43-697a8e58b191
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mixer
• Version Model Number: US9610
• Company DUNS: 342087108
• Company Name: Joline GmbH & Co. KG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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	04250203940917 [Primary]

FDA Product Code

• JDZ: Mixer, Cement, For Clinical Use

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