INTEGUSEAL

GUDID 05036912001625

IS200

ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITED

Surgical skin microbial sealant

• Primary Device ID: 05036912001625
• NIH Device Record Key: e4b79790-abf8-451c-8c25-6131bd7d87ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTEGUSEAL
• Version Model Number: 33737
• Company DUNS: 236059171
• Company Name: ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITED
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +448444125754
• Email: enquiries@admedsol.com
• Phone: +448444125754
• Email: enquiries@admedsol.com
• Phone: +448444125754
• Email: enquiries@admedsol.com
• Phone: +448444125754
• Email: enquiries@admedsol.com
• Phone: +448444125754
• Email: enquiries@admedsol.com
• Phone: +448444125754
• Email: enquiries@admedsol.com
• Phone: +448444125754
• Email: enquiries@admedsol.com
• Phone: +448444125754
• Email: enquiries@admedsol.com
• Phone: +448444125754
• Email: enquiries@admedsol.com
• Phone: +448444125754
• Email: enquiries@admedsol.com
• Phone: +448444125754
• Email: enquiries@admedsol.com
• Phone: +448444125754
• Email: enquiries@admedsol.com
• Phone: +448444125754
• Email: enquiries@admedsol.com
• Phone: +448444125754
• Email: enquiries@admedsol.com
• Phone: +448444125754
• Email: enquiries@admedsol.com
• Phone: +448444125754
• Email: enquiries@admedsol.com
• Phone: +448444125754
• Email: enquiries@admedsol.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05036912001625 [Primary]
GS1	05036912001632 [Package]; Package: Carton [10 Units]; In Commercial Distribution
GS1	05036912001649 [Package]; Contains: 05036912001632; Package: Shipper Carton [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052870

FDA Product Code

• NZP: Sealant, Microbial

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: 2024-12-04
• Device Publish Date: 2024-11-26

On-Brand Devices [INTEGUSEAL]

• 05036912001625: IS200
• 05036912001595: IS100