Director Biopsy/Needle Guide/Probe Cover Kit 4221(G)

GUDID 10841912105479

PROTEK MEDICAL PRODUCTS, INC.

Body-surface ultrasound imaging transducer cover

• Primary Device ID: 10841912105479
• NIH Device Record Key: a8c3f9c4-b76c-4c07-84dc-12f7b3aa138e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Director Biopsy/Needle Guide/Probe Cover Kit
• Version Model Number: 4221
• Catalog Number: 4221(G)
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841912105472 [Primary]
GS1	10841912105479 [Package]; Contains: 00841912105472; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970893

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: 5
• Public Version Date: 2019-10-07
• Device Publish Date: 2018-03-30

On-Brand Devices [Director Biopsy/Needle Guide/Probe Cover Kit]

• 10841912105479: 4221
• 00841912104468: 4222
• 00841912104451: 4220
• 00841912104444: 4218
• 00841912104437: 4216
• 10841912101136: 4222
• 10841912101129: 4220
• 10841912101112: 4218
• 00841912101108: 4216