Director Sterile Disposable Needle Guide 4022/TL

GUDID 00841912101061

PROTEK MEDICAL PRODUCTS, INC.

Nonimplantable needle guide, single-use

• Primary Device ID: 00841912101061
• NIH Device Record Key: f487c7ac-0c4a-49c1-8ba2-546d9e0c0f81
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Director Sterile Disposable Needle Guide
• Version Model Number: 4022/TL
• Catalog Number: 4022/TL
• Company DUNS: 965417181
• Company Name: PROTEK MEDICAL PRODUCTS, INC.
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841912101061 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K973958

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-07
• Device Publish Date: 2016-09-16

On-Brand Devices [Director Sterile Disposable Needle Guide]

• 10841912104502: 4016/TL
• 10841912101082: 4025
• 10841912101075: 4023
• 00841912101061: 4022/TL
• 10841912101051: 4022
• 10841912101044: 4021
• 10841912101020: 4019
• 00841912101016: 4018/TL
• 10841912101006: 4018
• 10841912100986: 4016
• 00841912100972: 4015/TL
• 10841912100962: 4015
• 10841912100955: 4014
• 00841912100941: 4013/TL
• 10841912100931: 4013