Leader

GUDID 10096295134473

Sterile Cotton Balls (130ct Medium Size)

U.S. COTTON, LLC

Cotton wool ball, sterile Cotton wool ball Cotton wool ball Cotton wool ball Cotton wool ball Cotton wool ball Cotton wool ball Cotton wool ball Cotton wool ball Cotton wool ball Cotton wool ball Cotton wool ball Cotton wool ball Cotton wool ball Cotton wool ball Cotton wool ball Cotton wool ball Cotton wool ball

• Primary Device ID: 10096295134473
• NIH Device Record Key: 62270feb-f094-4239-9a92-ba291a6a0774
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Leader
• Version Model Number: B FMDLS 0130 R02406 LEA
• Company DUNS: 932938897
• Company Name: U.S. COTTON, LLC
• Device Count: 130
• 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: true

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store indoors under normal ambient conditions in sealed package
• Special Storage Condition, Specify: Between 0 and 0 *Store indoors under normal ambient conditions in sealed package
• Special Storage Condition, Specify: Between 0 and 0 *Store indoors under normal ambient conditions in sealed package
• Special Storage Condition, Specify: Between 0 and 0 *Store indoors under normal ambient conditions in sealed package
• Special Storage Condition, Specify: Between 0 and 0 *Store indoors under normal ambient conditions in sealed package
• Special Storage Condition, Specify: Between 0 and 0 *Store indoors under normal ambient conditions in sealed package
• Special Storage Condition, Specify: Between 0 and 0 *Store indoors under normal ambient conditions in sealed package
• Special Storage Condition, Specify: Between 0 and 0 *Store indoors under normal ambient conditions in sealed package
• Special Storage Condition, Specify: Between 0 and 0 *Store indoors under normal ambient conditions in sealed package
• Special Storage Condition, Specify: Between 0 and 0 *Store indoors under normal ambient conditions in sealed package
• Special Storage Condition, Specify: Between 0 and 0 *Store indoors under normal ambient conditions in sealed package
• Special Storage Condition, Specify: Between 0 and 0 *Store indoors under normal ambient conditions in sealed package
• Special Storage Condition, Specify: Between 0 and 0 *Store indoors under normal ambient conditions in sealed package
• Special Storage Condition, Specify: Between 0 and 0 *Store indoors under normal ambient conditions in sealed package
• Special Storage Condition, Specify: Between 0 and 0 *Store indoors under normal ambient conditions in sealed package
• Special Storage Condition, Specify: Between 0 and 0 *Store indoors under normal ambient conditions in sealed package
• Special Storage Condition, Specify: Between 0 and 0 *Store indoors under normal ambient conditions in sealed package
• Special Storage Condition, Specify: Between 0 and 0 *Store indoors under normal ambient conditions in sealed package

Device Identifiers

Device Issuing Agency	Device ID
GS1	00096295134476 [Primary]
GS1	10048341800016 [Unit of Use]
GS1	10096295134473 [Package]; Contains: 00096295134476; Package: Case [24 Units]; In Commercial Distribution

FDA Product Code

• FRL: Fiber, Medical, Absorbent

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: 2020-03-09
• Device Publish Date: 2020-02-28

Devices Manufactured by U.S. COTTON, LLC

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• 10048341050145 - U.S. Cotton: 2021-02-22 Single Tip Polyester Swab, Plastic Stick
• 10048341800054 - U.S. Cotton: 2021-02-22 Cotton Balls (2000ct Medium Size)
• 10010939593334 - Sunmark: 2020-03-09 Sterile Cotton Balls (130ct Medium Size)
• 10011822311066 - Rite Aid: 2020-03-09 Sterile Cotton Roll (4 oz)
• 00036800186101 - TopCare: 2020-03-09 Sterile Cotton Balls (130ct Medium Size)