ESSENTIAL SURGICAL

GUDID 08056646502431

ESSENTIAL SURGICAL GOWN SMMS 35GR POUCHED - NO HANDTOWELS - SIZE M

OMNIA SRL

Surgical gown, single-use

• Primary Device ID: 08056646502431
• NIH Device Record Key: ee129bb2-02a0-40df-bb4b-23f1a9154247
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ESSENTIAL SURGICAL
• Version Model Number: 30.D2301.00
• Company DUNS: 447696675
• Company Name: OMNIA SRL
• 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: true
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +390524527453
• Email: info@omniaspa.eu
• Phone: +390524527453
• Email: info@omniaspa.eu
• Phone: +390524527453
• Email: info@omniaspa.eu
• Phone: +390524527453
• Email: info@omniaspa.eu
• Phone: +390524527453
• Email: info@omniaspa.eu
• Phone: +390524527453
• Email: info@omniaspa.eu
• Phone: +390524527453
• Email: info@omniaspa.eu
• Phone: +390524527453
• Email: info@omniaspa.eu
• Phone: +390524527453
• Email: info@omniaspa.eu
• Phone: +390524527453
• Email: info@omniaspa.eu
• Phone: +390524527453
• Email: info@omniaspa.eu
• Phone: +390524527453
• Email: info@omniaspa.eu
• Phone: +390524527453
• Email: info@omniaspa.eu
• Phone: +390524527453
• Email: info@omniaspa.eu
• Phone: +390524527453
• Email: info@omniaspa.eu

Device Identifiers

Device Issuing Agency	Device ID
GS1	08056646502431 [Primary]
GS1	18056646502438 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110724

FDA Product Code

• FYA: Gown, Surgical

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: 2020-04-10
• Device Publish Date: 2020-04-02

On-Brand Devices [ESSENTIAL SURGICAL ]

• 18056646502469: ESSENTIAL SURGICAL GOWN SMMS 35GR POUCHED - NO HANDTOWELS - SIZE XXL
• 18056646502452: ESSENTIAL SURGICAL GOWN SMMS 35GR POUCHED - NO HANDTOWELS - SIZE XL
• 18056646502445: ESSENTIAL SURGICAL GOWN SMMS 35GR POUCHED - NO HANDTOWELS - SIZE L
• 08056646502431: ESSENTIAL SURGICAL GOWN SMMS 35GR POUCHED - NO HANDTOWELS - SIZE M