ONETOUCH UitraSoft 2 Disposable Blood Lancet

GUDID 00385654001208

Sterilance Medical (usa), Inc.

Blood lancet, single-use

• Primary Device ID: 00385654001208
• NIH Device Record Key: 6f6dbd8e-db8c-45c9-8843-317048e1dafb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ONETOUCH UitraSoft 2 Disposable Blood Lancet
• Version Model Number: 01-0130
• Company DUNS: 939530262
• Company Name: Sterilance Medical (usa), Inc.
• 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: true
• 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	00385654001208 [Primary]
GS1	30385654001209 [Package]; Package: [50 Units]; In Commercial Distribution

FDA Product Code

• QRK: Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

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: 2023-02-09
• Device Publish Date: 2023-02-01