← Back to catalogue

Cook

FDA UDI

Class II (US FDA UDI)

by Cook Incorporated

Identity

Trade Name
COOK FDA UDI
Generic Name
Over-guidewire oesophageal dilator FDA UDI
Device Name
Savary Gilliard Dilator Washer FDA UDI
Model / Reference
G21653 FDA UDI
Description
Savary Gilliard Dilator Washer FDA UDI

Identifiers

Catalog Number
SGDW-1 FDA UDI
Primary DI / UDI-DI
00827002216532 FDA UDI
FDA Product Code
KNQ FDA UDI
GMDN Term
Over-guidewire oesophageal dilator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5365 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

No

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: Over-guidewire oesophageal dilator

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

Similar devices

Also classified as Over-guidewire oesophageal dilator.

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 367a2677-bb40-4b72-b0c6-4b3ec1abc15e 36 fields · synced Jun 6, 2026