STERiLANCE

GUDID 36945630142001

Sterilance Medical (Suzhou) Inc.

Manual blood lancing device, reusable

• Primary Device ID: 36945630142001
• NIH Device Record Key: 4beac85f-b867-469e-ad90-b2d5e73c208c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STERiLANCE
• Version Model Number: LDE4
• Company DUNS: 554434897
• Company Name: Sterilance Medical (Suzhou) 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	16945630142007 [Primary]
GS1	36945630142001 [Package]; Contains: 16945630142007; Package: [100 Units]; In Commercial Distribution

FDA Product Code

• QRL: Multiple Use Blood Lancet For Single Patient Use Only

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: 2026-03-17
• Device Publish Date: 2026-03-09

On-Brand Devices [STERiLANCE]

• 36945630112776: 01-0123
• 36945630112769: 01-0121
• 36945630113865: 02-2201
• 36945630141288: Soft 28G
• 36945630141295: SoftSure 28G
• 36945630141820: "Index Asurity SS#15 "
• 36945630142063: Lite3 30G 1.8mm
• 36945630142049: Soft 33G
• 36945630142032: Soft 32G
• 36945630142025: Soft 30G
• 36945630142018: Soft 28G
• 36945630142001: LDE4
• 06945630141997: Press2 26G 1.8mm
• 36945630141981: Elite 30G 1.8mm