Leader

GUDID 10096295134473

Sterile Cotton Balls (130ct Medium Size)

U.S. COTTON, LLC

Cotton wool ball, sterile

• 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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• 10048341050077 - U.S. Cotton: 2021-02-22 Single Tip Polyester Swab, Plastic stick
• 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)