OWELL

GUDID 00850044855339

OWELL Safety Lancets | 21g - 2.5mm | 100ct

OWELL

Manual blood lancing device, single-use

• Primary Device ID: 00850044855339
• NIH Device Record Key: 8dfe199a-0d91-40f2-99d7-17388bbb4ba1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OWELL
• Version Model Number: OWSL21G2.5MM-100
• Company DUNS: 123151704
• Company Name: OWELL
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850044855339 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222376

FDA Product Code

• FMK: Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-14
• Device Publish Date: 2025-08-06

On-Brand Devices [OWELL]

• 00850044855025: OWELL Lancing Device With Ejector
• 00850044855339: OWELL Safety Lancets | 21g - 2.5mm | 100ct
• 00850044855322: OWELL Safety Lancets | 23g - 2.2mm | 100ct
• 00850044855315: OWELL Safety Lancets | 26g - 1.8mm | 100ct
• 00850044855308: OWELL Safety Lancets | 30g - 1.5mm | 100ct