Heraeus Noblelight America LLC 8001 0768

GUDID 14054657500089

UV - Tanning lamp

G.L.E. Gesellschaft für lichttechnische Erzeugnisse mbH

Ultraviolet tanning device

• Primary Device ID: 14054657500089
• NIH Device Record Key: b1e5091b-62e7-4b1a-bc3b-d6c77cd48291
• Commercial Distribution Discontinuation: 2020-01-27
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Heraeus Noblelight America LLC
• Version Model Number: Strahler HNI MAT 1000 F
• Catalog Number: 8001 0768
• 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	04054657500570 [Primary]
GS1	14054657500089 [Previous]
GS1	14054657500577 [Package]; Contains: 04054657500570; Package: SecondaryPackaging [1 Units]; Discontinued: 2020-01-27; Not in Commercial Distribution
GS1	54054657600572 [Package]; Contains: 14054657500577; Package: CaseTertiary 100x [100 Units]; Discontinued: 2020-01-27; Not 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: 5
• Public Version Date: 2020-03-11
• Device Publish Date: 2017-02-28

On-Brand Devices [Heraeus Noblelight America LLC]

• 14054657500089: UV - Tanning lamp
• 14054657500539: UV - Tanning lamp, Accession # 1620 384-000 Exclusive distributor for USA: HN Sunlight GmbH
• 04054657500099: UV - Tanning lamp, Accession # 0631196-001 Exclusive distributor for USA: HN Sunlight GmbH,
• 54054657600534: UV - Tanning lamp, Accession # 1620 384-000 Exclusive distributor for USA: HN Sunlight GmbH
• 54054657600084: UV - Tanning lamp, Accession # 0631196-001 Exclusive distributor for USA: HN Sunlight GmbH,