← Back to catalogue

Entuit

FDA UDI

Class II (US FDA UDI)

by Cook Incorporated

Identity

Trade Name
Entuit FDA UDI
Generic Name
Gastrostomy T fastener FDA UDI
Device Name
Entuit Secure Gastrointestinal Suture Anchor Set FDA UDI
Model / Reference
G35570 FDA UDI
Description
Entuit Secure Gastrointestinal Suture Anchor Set FDA UDI

Identifiers

Catalog Number
GIAS-SRM-3 FDA UDI
Primary DI / UDI-DI
00827002355705 FDA UDI
FDA Product Code
FGE FDA UDI
GMDN Term
Gastrostomy T fastener FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5010 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Gastrostomy T fastener

Entuit by Cook Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Gastrostomy T fastener.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Cook Incorporated

Sources (1)

  • FDA UDI 3bd1004f-d9db-4ed6-ac0a-dfa9f15f7c12 36 fields · synced Jun 8, 2026