Terminator XR Sterile Drape TSD-100

GUDID 00841912100682

PROTEK MEDICAL PRODUCTS, INC.

Instrument/equipment drape, single-use, sterile

• Primary Device ID: 00841912100682
• NIH Device Record Key: 4f4051f8-618a-4a2a-ba65-996b0c4b24a4
• Commercial Distribution Discontinuation: 2018-06-06
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Terminator XR Sterile Drape
• Version Model Number: 1228
• Catalog Number: TSD-100
• 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	00841912100682 [Previous]
GS1	00841912105618 [Primary]
GS1	10841912100689 [Package]; Package: [20 Units]; Discontinued: 2018-06-06; Not in Commercial Distribution
GS1	10841912105615 [Package]; Contains: 00841912105618; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970885

FDA Product Code

• MMP: Cover, Barrier, Protective

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

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