OmniTrust 2155-43

GUDID 50810572004512

Powder Free Nitrile Examination Gloves Large

OMNI INTERNATIONAL CORP.

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

• Primary Device ID: 50810572004512
• NIH Device Record Key: eeb39f40-16b7-4788-85a5-bc363add7165
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OmniTrust
• Version Model Number: 2155-43
• Catalog Number: 2155-43
• Company DUNS: 079434709
• Company Name: OMNI INTERNATIONAL CORP.
• Device Count: 100
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810572004517 [Primary]
GS1	10810572004514 [Unit of Use]
GS1	50810572004512 [Package]; Contains: 00810572004517; Package: Shipper Carton [10 Units]; In Commercial Distribution

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: 2024-02-13
• Device Publish Date: 2024-02-05

On-Brand Devices [OmniTrust]

• 50810572004475: Nitrile Examination Gloves Powder Free XX-Large
• 50810572004468: Nitrile Examination Gloves Powder Free X-Large
• 50810572004451: Nitrile Examination Gloves Powder Free Large
• 50810572004444: Nitrile Examination Glove Powder Free Medium
• 50810572004437: Nitrile Examination Glove Powder Free Small
• 50810572004420: Nitrile Examination Glove Powder Free X-Small
• 50810572004536: Powder Free Nitrile Examination Gloves XX-Large
• 50810572004529: Powder Free Nitrile Examination Gloves X-Large
• 50810572004512: Powder Free Nitrile Examination Gloves Large
• 50810572004505: Powder Free Nitrile Examination Gloves Medium
• 50810572004499: Powder Free Nitrile Examination Gloves Small
• 50810572004482: Powder Free Nitrile Examination Gloves X-Small
• 50810572004598: OmniTrust Powder Free Synthetic Vinyl Examination Glove OEF X-Large
• 50810572004574: OmniTrust Powder Free Synthetic Vinyl Examination Glove OEF Medium
• 50810572004581: OmniTrust Powder Free Synthetic Vinyl Examination Glove OEF Large
• 50810572004567: OmniTrust Powder Free Synthetic Vinyl Examination Glove OEF Small
• 50810572004550: OmniTrust Powder Free Synthetic Vinyl Examination Glove OEF X-Small