Entuit GIAS-SRM-ADJ-3

GUDID 00827002355637

Entuit Secure Adjustable Gastrointestinal Suture Anchor Set

COOK INCORPORATED

Gastrostomy T fastener

• Primary Device ID: 00827002355637
• NIH Device Record Key: d5a5d87d-d49f-4b0c-b23d-623ffa5af16f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Entuit
• Version Model Number: G35563
• Catalog Number: GIAS-SRM-ADJ-3
• Company DUNS: 042823948
• Company Name: COOK INCORPORATED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: +1(812)330-5494
• Email: sharedservices@cookmedical.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00827002355637 [Primary]

FDA Product Code

• FGE: CATHETER, BILIARY, DIAGNOSTIC

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: 2018-05-31
• Device Publish Date: 2015-10-24

On-Brand Devices [Entuit]

• 00827002344440: Entuit Start Initial Placement Gastrostomy Set
• 00827002344433: Entuit Start Initial Placement Gastrostomy Set
• 00827002344426: Entuit Start Initial Placement Gastrostomy Set
• 00827002355705: Entuit Secure Gastrointestinal Suture Anchor Set
• 00827002355699: Entuit Secure Gastrointestinal Suture Anchor Set
• 00827002355637: Entuit Secure Adjustable Gastrointestinal Suture Anchor Set
• 00827002355620: Entuit Secure Adjustable Gastrointestinal Suture Anchor Set
• 10827002472911: Entuit Gastrostomy Set
• 10827002472904: Entuit Gastrostomy Set
• 10827002472898: Entuit Gastrostomy Set
• 10827002472881: Entuit Gastrostomy Set
• 10827002472874: Entuit Gastrostomy Set with ENFit Connection
• 10827002472867: Entuit Gastrostomy Set with ENFit Connection
• 10827002472850: Entuit Gastrostomy Set with ENFit Connection
• 10827002472843: Entuit Gastrostomy Set with ENFit Connection