STERiLANCE Impress Pro Disposable Safety Lancet

GUDID 36945630129491

Sterilance Medical (Suzhou) Inc.

Manual blood lancing device, single-use

• Primary Device ID: 36945630129491
• NIH Device Record Key: 85f7ecc6-a30c-455f-a696-232ac254b257
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STERiLANCE Impress Pro Disposable Safety Lancet
• Version Model Number: 05-192818
• Company DUNS: 554434897
• Company Name: Sterilance Medical (Suzhou) Inc.
• 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: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06945630129490 [Unit of Use]
GS1	16945630129497 [Primary]
GS1	36945630129491 [Package]; Contains: 16945630129497; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233796

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: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-31
• Device Publish Date: 2024-05-23

Devices Manufactured by Sterilance Medical (Suzhou) Inc.

• 36945630132439 - STERiLANCE Elite Disposable Safety Lancet: 2024-10-31
• 36945630132446 - STERiLANCE Elite Disposable Safety Lancet: 2024-10-31
• 36945630132460 - STERiLANCE Elite Disposable Safety Lancet: 2024-10-31
• 36945630132477 - STERiLANCE Press2 Disposable Safety Lancet: 2024-10-31
• 36945630132484 - STERiLANCE Press2 Disposable Safety Lancet: 2024-10-31
• 36945630132491 - STERiLANCE Press2 Disposable Safety Lancet: 2024-10-31
• 36945630132507 - STERiLANCE Press2 Disposable Safety Lancet: 2024-10-31
• 36945630132514 - STERiLANCE Flex3 Disposable Safety Lancet: 2024-10-31