DORMO-STRIP TCSS1

GUDID 28427734036925

Vein strippers are single use medical devices, sterilized by Ethylene Oxide, intended to be used for surgical stripping of varicose veins. This product is not intended to be used in the central venous system. Model VE-022 model is intended for conventional stripping procedures.

TELIC SAU

Vein stripper, single-use

• Primary Device ID: 28427734036925
• NIH Device Record Key: ab722677-077b-496a-b338-9eb7b0ecc21d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DORMO-STRIP
• Version Model Number: VE-022
• Catalog Number: TCSS1
• Company DUNS: 465170678
• Company Name: TELIC SAU
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	08427734036921 [Primary]
GS1	28427734036925 [Package]; Contains: 08427734036921; Package: Service box [12 Units]; In Commercial Distribution

FDA Product Code

• GAJ: Stripper, Vein, Disposable

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-23
• Device Publish Date: 2025-01-15