Probe Cover Kit 67234

GUDID 10841912105677

PROTEK MEDICAL PRODUCTS, INC.

Cable/lead/sensor/probe cover, sterile Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover

• Primary Device ID: 10841912105677
• NIH Device Record Key: 029d90a3-9f99-4b49-a592-956b842f0a51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Probe Cover Kit
• Version Model Number: 1467
• Catalog Number: 67234
• 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	00841912105670 [Primary]
GS1	10841912105677 [Package]; Contains: 00841912105670; Package: [20 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-09-17
• Device Publish Date: 2018-08-17

On-Brand Devices [Probe Cover Kit]

• 10841912105677: 1467
• 00841912104949: 2221
• 00841912104574: 1241
• 10841912104274: 2320
• 10841912100757: 1460
• 10841912100740: 1460
• 10841912100733: 1460
• 10841912100726: 1460
• 10841912100719: 1270
• 10841912100702: 1240
• 10841912100696: 1236
• 10841912100573: 1026
• 10841912100474: 2450
• 10841912100467: 2450
• 10841912100450: 2320
• 10841912100443: 2320
• 10841912100436: 2290
• 10841912100429: 2270
• 10841912100412: 2252
• 10841912100405: 2250
• 10841912100399: 2236
• 10841912100351: 2230
• 10841912100320: 2220
• 00841912100316: 2219
• 00841912100309: 2216
• 00841912100293: 2220
• 10841912100252: 2210
• 10841912100245: 2208