Sterile Bacteriostatic Lubricating Gel

GUDID 00858276007557

Sterile Bacteriostatic Lubricating Gel

Micro-tech Usa

General-body orifice lubricant

• Primary Device ID: 00858276007557
• NIH Device Record Key: 883ead02-de23-4942-a742-d8d871e64c94
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterile Bacteriostatic Lubricating Gel
• Version Model Number: MDJL1A0001A
• Company DUNS: 079873914
• Company Name: Micro-tech Usa
• Device Count: 1
• DM Exempt: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858276007557 [Primary]
GS1	00858276007564 [Package]; Package: Box [100 Units]; In Commercial Distribution
GS1	00858276007571 [Package]; Contains: 00858276007564; Package: Case [4 Units]; In Commercial Distribution

FDA Product Code

• KMJ: Lubricant, Patient

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: 2025-03-13
• Device Publish Date: 2025-03-05

Devices Manufactured by Micro-tech Usa

• 10850025860854 - CO2 Source Tubing Adapter Olympus UCR: 2025-05-20 CO2 Source Tubing Adapter, Olympus UCR CO2 Insufflator, Non-Sterile.
• 10850025860861 - CO2 Source Tubing Adapter Fuji GW100: 2025-05-20 CO2 Source Tubing Adapter, Fuji GW100 CO2 Insufflator, Non-Sterile.
• 10850025860908 - CO2 Source Tubing Filter Adapter Olympus: 2025-05-20 CO2 Source Tubing Filter Adapter Olympus, Sterile, Single Day Use.
• 10858276007974 - CO2 Source Tubing Filter Olympus: 2025-05-20 CO2 Source Tubing Filter Olympus, Sterile, Single Day Use.
• 10858276007981 - Endoscopy Kit - Compliance+ FUJ5 Kit: 2025-05-20 Endoscopy Kit, Compliance+, Sterile Lube 1.4oz, Gauze, Basin, FUJ5 Valve Set, Pad, Single Use
• 10850025860809 - Scope Tip Protector: 2025-03-19 Distal Tip Protector Small
• 10850025860816 - Scope Tip Protector: 2025-03-19 Distal Tip Protector Large
• 00850025860437 - Irrigation Tubing Set: 2025-03-17 Irrigation Tubing Set