Sterile Labels

GUDID B050SL1000021

Sterile Label Kit: 1 - 10 UP Custom Printed Label Sheet 1 - Utility Marker

TYPENEX MEDICAL LLC

Procedural medication labelling set

• Primary Device ID: B050SL1000021
• NIH Device Record Key: 180a264e-a90f-40b9-b6ff-3c138db88f20
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterile Labels
• Version Model Number: SL-100002
• Company DUNS: 600850213
• Company Name: TYPENEX MEDICAL LLC
• Device Count: 1
• 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: false
• Serial Number: false
• Manufacturing Date: false
• 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: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 75 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B050SL1000020 [Primary]
HIBCC	B050SL1000021 [Package]; Contains: B050SL1000020; Package: Case [25 Units]; In Commercial Distribution

FDA Product Code

• LYV: Label Or Tag, Sterile

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: 2026-03-25
• Device Publish Date: 2026-03-17

Devices Manufactured by TYPENEX MEDICAL LLC

• 20810050855833 - Microscope Slides: 2026-03-31 Liquid Based Cytology Slides, Uncoated, Single Circle on Front, Ground Edge, 45° Corners, Blue (LC0105B)
• B050SL1000021 - Sterile Labels: 2026-03-25Sterile Label Kit: 1 - 10 UP Custom Printed Label Sheet 1 - Utility Marker
• B050SL1000021 - Sterile Labels: 2026-03-25 Sterile Label Kit: 1 - 10 UP Custom Printed Label Sheet 1 - Utility Marker
• 00810050855815 - ThermoFlo®: 2026-02-03 ThermoFlo Heat and Moisture Exchanger, Elbow
• 10810050855805 - Typenex Introducer Set: 2025-11-25 Micro Introducer: 4F x 20cm, Smooth Tip Needle, 0.018 Nitinol/AU Wire, Stiffen Dilator
• 10810050855782 - Fibernex Laser System: 2025-08-05 Fibernex Go Laser System
• 20810050855772 - Microscope Slides: 2025-07-22 Liquid Based Cytology Slides, Uncoated, Single Circle, Ground Edge, 45° Corners, Blue (LC0104B)
• 20810050855765 - Microscope Slides: 2025-07-16 Premium Microscope Slide, Ground Edges, 45° Corners, White (PS0204W)
• 20810050855741 - Microscope Slides: 2025-06-25 Premium Microscope Slide, Positive Charged, Thermal Printing, Ground Edges, 45° Corners - White Frosted (PS0404WXT)