Enclose II® EN235v

GUDID 00852621004185

Anastomosis assist device

VITALITEC INTERNATIONAL, INC.

Vascular clamp, reusable

• Primary Device ID: 00852621004185
• NIH Device Record Key: 2661cd89-4781-421c-bd4d-68cc4aa12300
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Enclose II®
• Version Model Number: EN235v
• Catalog Number: EN235v
• Company DUNS: 121464288
• Company Name: VITALITEC INTERNATIONAL, INC.
• 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: true
• Device Combination Product: false
• Single Use: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 5087476033
• Email: eknupp@aol.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852621004185 [Primary]
GS1	10852621004182 [Package]; Package: Case [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032589

FDA Product Code

• DXC: Clamp, Vascular

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-26

On-Brand Devices [Enclose II®]

• 00852621004208: Anastomosis assist device
• 00852621004192: Anastomosis assist device
• 00852621004185: Anastomosis assist device