index Asurity

GUDID 36945630137601

Sterilance Medical (Suzhou) Inc.

Manual scalpel blade, single-use

• Primary Device ID: 36945630137601
• NIH Device Record Key: f1f03b5e-adca-4e6b-add6-9fa50606934d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: index Asurity
• Version Model Number: Index Asurity 4# SS 22#
• Company DUNS: 554434897
• Company Name: Sterilance Medical (Suzhou) Inc.
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06945630137600 [Unit of Use]
GS1	16945630137607 [Primary]
GS1	36945630137601 [Package]; Contains: 16945630137607; Package: [3 Units]; In Commercial Distribution

FDA Product Code

• GDX: Scalpel, One-Piece

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: 2025-09-03
• Device Publish Date: 2025-08-26

On-Brand Devices [index Asurity]

• 36945630137632: Index Asurity 4#
• 36945630137625: Index Asurity 3#
• 36945630139070: Index Asurity 3# SS 13#
• 36945630139063: Index Asurity 3# SS 10#
• 36945630137618: Index Asurity 4# SS 23#
• 36945630137601: Index Asurity 4# SS 22#
• 36945630137595: Index Asurity 3# SS 15#
• 36945630137588: Index Asurity 3# SS 11#