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

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• 10850025860816 - Scope Tip Protector: 2025-03-19 Distal Tip Protector Large
• 00850025860437 - Irrigation Tubing Set: 2025-03-17 Irrigation Tubing Set
• 00858276007557 - Sterile Bacteriostatic Lubricating Gel: 2025-03-13Sterile Bacteriostatic Lubricating Gel
• 00858276007557 - Sterile Bacteriostatic Lubricating Gel: 2025-03-13 Sterile Bacteriostatic Lubricating Gel
• 00850025860406 - Air/Water Bottle CO2 Tubing: 2025-03-12 Air/Water Bottle CO2 Tubing Olympus
• 00850025860468 - Air/Water Bottle Tubing: 2025-03-12 Air/Water Bottle Tubing Olympus
• 10850025860489 - Endoscopy Kit - Basic + Gowns: 2025-03-12 Endoscopy Kit - Basic + Gowns
• 00850025860574 - 4-Piece Valve Kit: 2025-03-12 A/W Suction Valve Kit Lub Pen 4 Piece