Entuit

Basic Information

• Brand Name: Entuit
• Primary DI: 00827002355705
• Version / Model: G35570
• Catalog Number: GIAS-SRM-3
• Company Name: COOK INCORPORATED
• Labeler DUNS: 042823948
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-24
• Public Version: 3
• Public Version Date: 2018-05-31
• Public Version Status: Update
• Public Device Record Key: 3bd1004f-d9db-4ed6-ac0a-dfa9f15f7c12

Device Description

Entuit Secure Gastrointestinal Suture Anchor Set

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FGE	CATHETER, BILIARY, DIAGNOSTIC	Gastroenterology, Urology	876.5010	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17789	Gastrostomy T fastener	A device inserted into the stomach percutaneously to appose the anterior gastric wall to the anterior abdominal wall, typically to facilitate the insertion of a percutaneous gastrostomy tube or for procedures requiring stabilization/fixation of hollow gastrointestinal (GI) structures. It consists of a metal T-bar, usually with an attached plastic suture. It is typically positioned within a longitudinal side slot in a needle; the needle with the suture is introduced into the gastric lumen and the T-bar is then moved into the lumen, the suture is pulled back against the stomach wall and a cotton pledget anchors it outside the abdominal wall. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00827002355705	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in dark, dry, cool place.