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SafeGuide®

FDA UDI

Class II (US FDA UDI)

by Diversatek Healthcare

Identity

Trade Name
SafeGuide® FDA UDI
Generic Name
Over-guidewire oesophageal dilator FDA UDI
Device Name
Esophageal Dilator, 57 French FDA UDI
Model / Reference
1214-57 FDA UDI
Description
Esophageal Dilator, 57 French FDA UDI

Identifiers

Catalog Number
1214-57 FDA UDI
Primary DI / UDI-DI
00816734021170 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

No

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
High-level Disinfectant FDA UDI

Dimensions & Sizes

Size
Catheter Gauge — 57 French FDA UDI

Category: Over-guidewire oesophageal dilator

SafeGuide® by Diversatek Healthcare — 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

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Manufacturer

Manufacturer
Diversatek Healthcare

Sources (1)

  • FDA UDI 5b4f7b09-b960-4ef9-9507-dff2f3f6453f 36 fields · synced May 30, 2026