Probe Cover Kit 2252

GUDID 10841912100412

PROTEK MEDICAL PRODUCTS, INC.

Cable/lead/sensor/probe cover, sterile

• Primary Device ID: 10841912100412
• NIH Device Record Key: bcd47af2-1954-45a3-9782-8fe5adf5a6e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Probe Cover Kit
• Version Model Number: 2252
• Catalog Number: 2252
• 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: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841912100415 [Primary]
GS1	10841912100412 [Package]; Contains: 00841912100415; Package: [24 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

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