Rite Aid

GUDID 10011822615393

Precision Freeze Wart Remover System

Orasure Technologies, Inc.

General cryosurgical system, cryogen gas, mechanical

• Primary Device ID: 10011822615393
• NIH Device Record Key: b31f317d-5b4e-4860-a1df-98a8fed10cc9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rite Aid
• Version Model Number: 0361539
• Company DUNS: 114152184
• Company Name: Orasure Technologies, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: true

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from Sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00011822615396 [Primary]
GS1	10011822615393 [Package]; Contains: 00011822615396; Package: [6 Units]; In Commercial Distribution

FDA Product Code

• GEH: Unit, Cryosurgical, Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-04-07
• Device Publish Date: 2016-09-27

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