droplet®, pen needles 7497

GUDID 85907996099395

Sterile single use droplet® pen needles, intended to be used with a pen injector device for the subcutaneous injection of drugs.

HTL STREFA S A

Autoinjector needle

• Primary Device ID: 85907996099395
• NIH Device Record Key: 518a48d4-ecea-4ba7-bddb-17d851fa2fb7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: droplet®, pen needles
• Version Model Number: 31G x 5 mm
• Catalog Number: 7497
• Company DUNS: 422528088
• Company Name: HTL STREFA S A
• Device Count: 100
• 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: 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05907996099399 [Primary]
GS1	15907996099396 [Package]; Contains: 05907996099399; Package: shipper [24 Units]; In Commercial Distribution
GS1	85907996099395 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171982

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

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: 2020-12-01
• Device Publish Date: 2020-11-23

On-Brand Devices [droplet®, pen needles]

• 15907996099419: Sterile single use droplet® pen needles, intended to be used with a pen injector device for the
• 15907996099402: Sterile single use droplet® pen needles, intended to be used with a pen injector device for the
• 85907996099395: Sterile single use droplet® pen needles, intended to be used with a pen injector device for the
• 85907996099388: Sterile single use droplet® pen needles, intended to be used with a pen injector device for the