Ally UPS Adapter Drape for Advincula Delineator

GUDID 20888937019951

Sterile drape

Coopersurgical, Inc.

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• Primary Device ID: 20888937019951
• NIH Device Record Key: 40cb727b-dc07-4c28-bfe7-1ed77808f106
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ally UPS Adapter Drape for Advincula Delineator
• Version Model Number: AU-AD-DLNTR
• Company DUNS: 801895244
• Company Name: Coopersurgical, 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888937019957 [Primary]
GS1	20888937019951 [Package]; Contains: 00888937019957; Package: Box [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141523

FDA Product Code

• LKF: Cannula, Manipulator/Injector, Uterine

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-06
• Device Publish Date: 2018-12-03

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