droplet Genteel lancing device 9150

GUDID 15907996098771

The Droplet Genteel Lancing Device is used with disposable lancets to draw capillary blood from the fingertip or alternate sites for glucose testing or other testing utilizing small amount of blood.

HTL STREFA S A

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• Primary Device ID: 15907996098771
• NIH Device Record Key: cdfd18a6-50f0-4029-b8fc-766d0e0d317b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: droplet Genteel lancing device
• Version Model Number: n/a
• Catalog Number: 9150
• Company DUNS: 422528088
• Company Name: HTL STREFA S A
• 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: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05907996098774 [Primary]
GS1	15907996098771 [Package]; Contains: 05907996098774; Package: shipper box [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153670

FDA Product Code

• FMK: Lancet, Blood

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-10-01
• Device Publish Date: 2021-04-20

Devices Manufactured by HTL STREFA S A

• 50096295142995 - LEADER, pen needles: 2024-01-25 LEADER pen needles are sterile, single-use pen needles intended for use with pen injector devicec for the subcutaneous injection
• 10096295143000 - LEADER, pen needles: 2024-01-25 LEADER pen needles are sterile, single-use pen needles intended for use with pen injector devicec for the subcutaneous injection
• 15907996099976 - DropSafe™ Inject-Safe Barrier Bandage™: 2023-07-03 Barrier Bandage it’s intended to contain post-injection bleeding during a subcutaneous or intramuscular injection. The device
• 15903999603080 - Safe-T-Lance Plus, safety lancets: 2023-04-06 Safety lancets are sterile, single use medical devices intended for capillary blood sampling. Intended users are healthcare prof
• 15903999603097 - Safe-T-Lance Plus, safety lancets: 2023-04-06 Safety lancets are sterile, single use medical devices intended for capillary blood sampling. Intended users are healthcare prof
• 15903999603103 - Safe-T-Lance Plus, safety lancets: 2023-04-06 Safety lancets are sterile, single use medical devices intended for capillary blood sampling. Intended users are healthcare prof
• 15903999603110 - Safe-T-Lance Plus, safety lancets: 2023-04-06 Safety lancets are sterile, single use medical devices intended for capillary blood sampling. Intended users are healthcare prof
• 15903999603127 - Safe-T-Lance Plus, safety lancets: 2023-04-06 Safety lancets are sterile, single use medical devices intended for capillary blood sampling. Intended users are healthcare prof