Rexall DG4345

GUDID 10197344110056

GLOVE,EXAM,NITRIL,PF,30CT,OSFM,DG

DOLGENCORP, LLC

Nitrile examination/treatment glove, non-powdered, non-antimicrobial

• Primary Device ID: 10197344110056
• NIH Device Record Key: 4c64a277-3f67-48f7-a496-e70925942a9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rexall
• Version Model Number: DG4345
• Catalog Number: DG4345
• Company DUNS: 068331990
• Company Name: DOLGENCORP, LLC
• Device Count: 30
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00197344110059 [Primary]
GS1	10197344110056 [Package]; Contains: 00197344110059; Package: ZI [3 Units]; In Commercial Distribution
GS1	20197344110053 [Package]; Contains: 00197344110059; Package: CS [24 Units]; In Commercial Distribution
GS1	80197344110055 [Unit of Use]

FDA Product Code

• LZA: Polymer Patient Examination Glove

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-16
• Device Publish Date: 2024-08-08

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• 10197344110056: GLOVE,EXAM,NITRIL,PF,30CT,OSFM,DG