Silverstream OTC FBS-01-1-OSS-1000-01

GUDID 27290019690102

SilverStream OTC 250ml: SilverStream® OTC is a hypertonic buffered solution, with hydrogel properties, for skin wounds and burns management and maintenance of moisture level.

SilverStream Medical Ltd.

Antimicrobial wound irrigation solution

• Primary Device ID: 27290019690102
• NIH Device Record Key: 4ee6b744-92be-4fbf-b2f2-578adc27b336
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silverstream OTC
• Version Model Number: SS-1000-01
• Catalog Number: FBS-01-1-OSS-1000-01
• Company DUNS: 533346805
• Company Name: SilverStream Medical Ltd.
• Device Count: 1
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +14708633009
• Email: eyal@silverstreammed.com
• Phone: +14708633009
• Email: eyal@silverstreammed.com
• Phone: +14708633009
• Email: eyal@silverstreammed.com
• Phone: +14708633009
• Email: eyal@silverstreammed.com
• Phone: +14708633009
• Email: eyal@silverstreammed.com
• Phone: +14708633009
• Email: eyal@silverstreammed.com
• Phone: +14708633009
• Email: eyal@silverstreammed.com
• Phone: +14708633009
• Email: eyal@silverstreammed.com
• Phone: +14708633009
• Email: eyal@silverstreammed.com
• Phone: +14708633009
• Email: eyal@silverstreammed.com
• Phone: +14708633009
• Email: eyal@silverstreammed.com
• Phone: +14708633009
• Email: eyal@silverstreammed.com
• Phone: +14708633009
• Email: eyal@silverstreammed.com
• Phone: +14708633009
• Email: eyal@silverstreammed.com
• Phone: +14708633009
• Email: eyal@silverstreammed.com
• Phone: +14708633009
• Email: eyal@silverstreammed.com
• Phone: +14708633009
• Email: eyal@silverstreammed.com
• Phone: +14708633009
• Email: eyal@silverstreammed.com

Device Dimensions

• Total Volume: 250 Milliliter
• Total Volume: 250 Milliliter
• Total Volume: 250 Milliliter
• Total Volume: 250 Milliliter
• Total Volume: 250 Milliliter
• Total Volume: 250 Milliliter
• Total Volume: 250 Milliliter
• Total Volume: 250 Milliliter
• Total Volume: 250 Milliliter
• Total Volume: 250 Milliliter
• Total Volume: 250 Milliliter
• Total Volume: 250 Milliliter
• Total Volume: 250 Milliliter
• Total Volume: 250 Milliliter
• Total Volume: 250 Milliliter
• Total Volume: 250 Milliliter
• Total Volume: 250 Milliliter
• Total Volume: 250 Milliliter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290019690108 [Primary]
GS1	27290019690102 [Package]; Contains: 07290019690108; Package: Carton [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093227

FDA Product Code

• FRO: Dressing, Wound, Drug

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: 2024-05-27
• Device Publish Date: 2024-05-19

On-Brand Devices [Silverstream OTC]

• 27290019690119: SilverStream OTC 500 ml: SilverStream® OTC is a hypertonic buffered solution, with hydrogel pro
• 27290019690102: SilverStream OTC 250ml: SilverStream® OTC is a hypertonic buffered solution, with hydrogel prop
• 17290019690099: SilverStream OTC 100ml: SilverStream® OTC is a hypertonic buffered solution, with hydrogel prop