PullUp Instrument Cover 1003

GUDID 00841912100491

PROTEK MEDICAL PRODUCTS, INC.

Instrument/equipment drape, single-use, sterile

• Primary Device ID: 00841912100491
• NIH Device Record Key: 1576870c-25b5-4a84-a65f-be553c6b41d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PullUp Instrument Cover
• Version Model Number: 1003
• Catalog Number: 1003
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841912100491 [Primary]
GS1	10841912100498 [Package]; Package: [24 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

On-Brand Devices [PullUp Instrument Cover]

• 10841912100603: 1030
• 00841912100491: 1003
• 10841912106063: 1042