HSEU 5702546

GUDID 20304040151383

An aqueous based 15.5% Ferric Sulfate solution, which is excellent for soaking retraction cord, eliminating sulcular fluid contamination, aiding gingival retraction and reducing mucous membrane inflammation.

HENRY SCHEIN, INC.

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• Primary Device ID: 20304040151383
• NIH Device Record Key: 1206a3de-42be-4488-a9f9-4e06cc118084
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HSEU
• Version Model Number: 5702546
• Catalog Number: 5702546
• Company DUNS: 012430880
• Company Name: HENRY SCHEIN, INC.
• Device Count: 4
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store between 2-30C
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2-30C
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2-30C
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2-30C
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2-30C
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2-30C
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2-30C
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2-30C
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2-30C
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2-30C
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2-30C
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2-30C
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2-30C
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2-30C
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2-30C
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2-30C
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2-30C
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2-30C
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2-30C
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2-30C
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2-30C
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2-30C
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2-30C
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2-30C
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2-30C
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2-30C
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2-30C
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2-30C
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00304040151389 [Unit of Use]
GS1	10304040151386 [Primary]
GS1	20304040151383 [Package]; Contains: 10304040151386; Package: Case [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193389

FDA Product Code

• MVL: CORD, RETRACTION

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: 2021-03-22
• Device Publish Date: 2021-03-12

On-Brand Devices [HSEU]

• 20304040151444: Intended for sulcus retraction prior to impression making and to control bleeding and gingival o
• 20304040151383: An aqueous based 15.5% Ferric Sulfate solution, which is excellent for soaking retraction cord,
• 10304040151430: An aqueous based 15.5% Ferric Sulfate solution, which is excellent for soaking retraction cord,
• 10304040151423: An aqueous based 21.3% Aluminum Chloride solution, which is excellent for soaking retraction cor
• 10304040151409: 20% ferric sulfate gel used for immediate and profound control of bleeding. This gel works on bo
• 10304040151393: An aqueous based 15.5% Ferric Sulfate solution, which is excellent for soaking retraction cord,
• 10304040151379: 20% ferric sulfate gel used for immediate and profound control of bleeding. This gel works on bo
• 20304040151413: Retreat Hemostatic Gel Kit 20% FS