← Back to catalogue

Entuit

FDA UDI

Class II (US FDA UDI)

by Cook Incorporated

Identity

Trade Name
Entuit FDA UDI
Generic Name
Gastrostomy tube kit, non-medicated FDA UDI
Device Name
Entuit Gastrostomy Set with ENFit Connection FDA UDI
Model / Reference
G47285 FDA UDI
Description
Entuit Gastrostomy Set with ENFit Connection FDA UDI

Identifiers

Catalog Number
C-ENTUIT-16-M-ENF FDA UDI
Primary DI / UDI-DI
10827002472850 FDA UDI
FDA Product Code
PRR FDA UDI
GMDN Term
Gastrostomy tube kit, non-medicated FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5980 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Gastrostomy tube kit, non-medicated

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

Similar devices

Also classified as Gastrostomy tube kit, non-medicated.

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 404be157-3e43-4f06-acc2-cbb926acc899 36 fields · synced Jun 8, 2026