Sterile Sleeve for Gamma Finder III 1031

GUDID 00841912105885

PROTEK MEDICAL PRODUCTS, INC.

Medical equipment drape, single-use

• Primary Device ID: 00841912105885
• NIH Device Record Key: bedf6e0e-d3bb-4432-9bbb-117911429bdf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterile Sleeve for Gamma Finder III
• Version Model Number: 1031
• Catalog Number: 1031
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841912105885 [Previous]
GS1	00841912106035 [Primary]
GS1	10841912106032 [Package]; Contains: 00841912106035; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970889

FDA Product Code

• KKX: Drape, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-06
• Device Publish Date: 2019-06-10

Devices Manufactured by PROTEK MEDICAL PRODUCTS, INC.

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• 10841912106513 - Sterile Protective Barrier Kit: 2024-07-25
• 10841912106520 - Sterile Protective Barrier Kit: 2024-07-25
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• 00841912106745 - Biopsy Starter Kit: 2022-06-10 Biopsy Starter Kit for Mindray L12-4s, 7L4s, L14-6Ns, L14-6NE & L12-3E Ultrasound Transducers
• 10841912107107 - Sterile Disposable Endocavity Needle Guide: 2022-04-11 Sterile Disposable Endocavity Needle Guide for Ultrasound Transducers