Surgical Blade Carbon Steel

GUDID 36945630112080

Sterilance Medical (Suzhou) Inc.

Manual scalpel blade, single-use Manual scalpel blade, single-use Manual scalpel blade, single-use Manual scalpel blade, single-use Manual scalpel blade, single-use Manual scalpel blade, single-use

• Primary Device ID: 36945630112080
• NIH Device Record Key: 1a26bb30-b3ca-4fcb-854f-50f096d4918a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Surgical Blade Carbon Steel
• Version Model Number: 60#
• Company DUNS: 554434897
• Company Name: Sterilance Medical (Suzhou) Inc.
• Device Count: 100
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06945630112089 [Unit of Use]
GS1	16945630112086 [Primary]
GS1	36945630112080 [Package]; Contains: 16945630112086; Package: [5000 Units]; In Commercial Distribution

FDA Product Code

• GES: Blade, Scalpel

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: 2022-05-18
• Device Publish Date: 2022-05-10

Devices Manufactured by Sterilance Medical (Suzhou) Inc.

• 06945630125522 - STERiLANCE SteriHeel Plus Heel Incision Safety Lancet: 2024-04-17
• 26945630125120 - Disposable Safety Lancet Press2: 2024-04-08
• 36945630121808 - neoheel: 2024-02-16
• 36945630121815 - neoheel: 2024-02-16
• 06945630121821 - neoheel: 2024-02-16
• 36945630124106 - neoheel: 2024-02-16
• 26945630122846 - Soft: 2024-02-08
• 26945630122853 - Soft: 2024-02-08