Ultratan 8004 0915

GUDID 04054657500464

UV - Tanning lamp

G.L.E. Gesellschaft für lichttechnische Erzeugnisse mbH

Ultraviolet tanning device

• Primary Device ID: 04054657500464
• NIH Device Record Key: ca6fe841-cf97-488c-8d32-75063fa42125
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultratan
• Version Model Number: Strahler Collagentex 31/51 EC
• Catalog Number: 8004 0915
• Company DUNS: 312827900
• Company Name: G.L.E. Gesellschaft für lichttechnische Erzeugnisse mbH
• 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: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• 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

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	04054657500464 [Primary]
GS1	14054657500461 [Package]; Package: SecondaryPackaging [1 Units]; In Commercial Distribution
GS1	54054657600466 [Package]; Contains: 14054657500461; Package: CaseTertiary 100x [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151674

FDA Product Code

• LEJ: Booth, Sun Tan

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: 2020-03-18
• Device Publish Date: 2017-02-28

Devices Manufactured by G.L.E. Gesellschaft für lichttechnische Erzeugnisse mbH

• 04054657500037 - Megaline: 2020-03-18 UV - Tanning lamp
• 04054657500051 - JK: 2020-03-18 UV - Tanning lamp
• 04054657500198 - Original Hanau: 2020-03-18 UV - Tanning lamp
• 54054657600220 - Original Hanau: 2020-03-18 UV - Tanning lamp
• 54054657600237 - Original Hanau: 2020-03-18 UV - Tanning lamp
• 14054657500256 - Original Hanau: 2020-03-18 UV - Tanning lamp
• 14054657500270 - Original Hanau: 2020-03-18 UV - Tanning lamp
• 04054657500297 - Original Hanau: 2020-03-18 UV - Tanning lamp