DropSafe Haemolance Plus, safety lancets 9634

GUDID 15903999602236

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

Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use

• Primary Device ID: 15903999602236
• NIH Device Record Key: 4b90b4a8-a565-4fc1-9aec-31df4df19ce1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DropSafe Haemolance Plus, safety lancets
• Version Model Number: 21G x 1.8mm
• Catalog Number: 9634
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05903999602239 [Primary]
GS1	15903999602236 [Package]; Contains: 05903999602239; Package: shipper box [10 Units]; In Commercial Distribution
GS1	85903999602235 [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: 2022-11-16
• Device Publish Date: 2022-11-08

On-Brand Devices [DropSafe Haemolance Plus, safety lancets]

• 15903999602212: Safety lancets are sterile, single use medical devices intended for capillary blood sampling. In
• 15903999602342: Safety lancets are sterile, single use medical devices intended for capillary blood sampling. In
• 15903999602335: Safety lancets are sterile, single use medical devices intended for capillary blood sampling. In
• 15903999602328: Safety lancets are sterile, single use medical devices intended for capillary blood sampling. In
• 15903999602311: Safety lancets are sterile, single use medical devices intended for capillary blood sampling. In
• 15903999602304: Safety lancets are sterile, single use medical devices intended for capillary blood sampling. In
• 15903999602298: Safety lancets are sterile, single use medical devices intended for capillary blood sampling. In
• 15903999602267: Safety lancets are sterile, single use medical devices intended for capillary blood sampling. In
• 15903999602250: Safety lancets are sterile, single use medical devices intended for capillary blood sampling. In
• 85903999602242: Safety lancets are sterile, single use medical devices intended for capillary blood sampling. In
• 15903999602236: Safety lancets are sterile, single use medical devices intended for capillary blood sampling. In
• 15903999602229: Safety lancets are sterile, single use medical devices intended for capillary blood sampling. In