DropSafe ergoLance, safety lancets 9655

GUDID 15903999602465

Safety lancets are sterile, single use medical devices intended for capillary blood sampling. Intended users are healthcare professionals and lay users.

HTL STREFA S A

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• Primary Device ID: 15903999602465
• NIH Device Record Key: 5893330f-e03e-4e1b-b3f5-73e43a50859f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DropSafe ergoLance, safety lancets
• Version Model Number: 21G x 2.0 mm
• Catalog Number: 9655
• Company DUNS: 422528088
• Company Name: HTL STREFA S A
• Device Count: 200
• 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: 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: false

Customer Support Contacts

• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com
• Phone: +48422700010
• Email: info@htl-strefa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05903999602468 [Primary]
GS1	15903999602465 [Package]; Contains: 05903999602468; Package: shipper box [10 Units]; In Commercial Distribution
GS1	85903999602464 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220643

FDA Product Code

• FMK: Lancet, Blood

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: 2022-11-14
• Device Publish Date: 2022-11-06

On-Brand Devices [DropSafe ergoLance, safety lancets]

• 15903999602465: Safety lancets are sterile, single use medical devices intended for capillary blood sampling. In
• 15903999602458: Safety lancets are sterile, single use medical devices intended for capillary blood sampling. In
• 15903999602441: Safety lancets are sterile, single use medical devices intended for capillary blood sampling. In
• 15903999602434: Safety lancets are sterile, single use medical devices intended for capillary blood sampling. In
• 15903999602427: Safety lancets are sterile, single use medical devices intended for capillary blood sampling. In
• 85903999602419: Safety lancets are sterile, single use medical devices intended for capillary blood sampling. In