Instant White Label 09397116001

GUDID 00365702702684

IWL Lancets 10ct

Roche Diagnostics Operations, Inc.

Manual blood lancing device, reusable

• Primary Device ID: 00365702702684
• NIH Device Record Key: 396edc86-3c71-4e93-8bfd-55f90e9909df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Instant White Label
• Version Model Number: 09397116001
• Catalog Number: 09397116001
• Company DUNS: 141608724
• Company Name: Roche Diagnostics Operations, 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: 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	00365702702684 [Primary]

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: 2022-10-31
• Device Publish Date: 2022-10-21

Devices Manufactured by Roche Diagnostics Operations, Inc.

• 00365702702417 - ACCU-CHEK GUIDE LINK: 2023-09-29 ACCU-CHEK GUIDE LINK MG/DL 118
• 10365702702889 - ACCU-CHEK GUIDE LINK: 2023-09-29 ACCU-CHEK GUIDE LINK SAMPLE mg/dl MO US
• 10365702702476 - ACCU-CHEK GUIDE LINK: 2023-09-14 Accu-Chek Guide Link SC mg/dL
• 10365702702537 - ACCU-CHEK GUIDE LINK: 2023-09-14 Accu-Chek Guide Link MO Replacement US
• 10365702702803 - Accu-Chek Fastclix: 2023-03-30 Accu-Chek Fastclix Kit Canada
• 10365702702827 - Accu-Chek Softclix: 2023-03-30 Accu-Chek Softclix Kit Canada
• 00365702702684 - Instant White Label: 2022-10-31IWL Lancets 10ct
• 00365702702684 - Instant White Label: 2022-10-31 IWL Lancets 10ct
• 10075537257897 - Accu-Chek Safe-T-Pro: 2022-10-27 Accu-Chek Safe-T-Pro Plus 200ct