ELASTEX 2 1127026

GUDID 10304040040291

ELASTEX 2 LARGE

HENRY SCHEIN, INC.

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

• Primary Device ID: 10304040040291
• NIH Device Record Key: f57e6bad-3197-40cc-9a87-b4ff923102b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELASTEX 2
• Version Model Number: 1127026
• Catalog Number: 1127026
• Company DUNS: 012430880
• Company Name: HENRY SCHEIN, INC.
• Device Count: 200
• DM Exempt: true
• 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

• Special Storage Condition, Specify: Between 0 and 0 *FALSE
• Special Storage Condition, Specify: Between 0 and 0 *FALSE
• Special Storage Condition, Specify: Between 0 and 0 *FALSE
• Special Storage Condition, Specify: Between 0 and 0 *FALSE
• Special Storage Condition, Specify: Between 0 and 0 *FALSE
• Special Storage Condition, Specify: Between 0 and 0 *FALSE
• Special Storage Condition, Specify: Between 0 and 0 *FALSE
• Special Storage Condition, Specify: Between 0 and 0 *FALSE
• Special Storage Condition, Specify: Between 0 and 0 *FALSE
• Special Storage Condition, Specify: Between 0 and 0 *FALSE
• Special Storage Condition, Specify: Between 0 and 0 *FALSE
• Special Storage Condition, Specify: Between 0 and 0 *FALSE
• Special Storage Condition, Specify: Between 0 and 0 *FALSE
• Special Storage Condition, Specify: Between 0 and 0 *FALSE
• Special Storage Condition, Specify: Between 0 and 0 *FALSE
• Special Storage Condition, Specify: Between 0 and 0 *FALSE
• Special Storage Condition, Specify: Between 0 and 0 *FALSE
• Special Storage Condition, Specify: Between 0 and 0 *FALSE
• Special Storage Condition, Specify: Between 0 and 0 *FALSE

Device Identifiers

Device Issuing Agency	Device ID
GS1	00304040040294 [Primary]
GS1	10304040040291 [Package]; Contains: 00304040040294; Package: [10 Units]; In Commercial Distribution
GS1	20304040040298 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102074

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: 2019-05-16
• Device Publish Date: 2019-05-08

On-Brand Devices [ELASTEX 2]

• 10304040040307: ELASTEX 2 X LARGE
• 10304040040291: ELASTEX 2 LARGE
• 10304040040284: ELASTEX 2 MEDIUM
• 10304040040277: ELASTEX 2 X SMALL
• 10304040040260: ELASTEX 2 SMALL