← Back to catalogue

Edge

FDA UDI

Class II (US FDA UDI)

by Covidien LP

Identity

Trade Name
Edge FDA UDI
Generic Name
Bronchoscopic catheter FDA UDI
Device Name
Firm Tip; Endobronchial Procedure Kit;45 Catheter FDA UDI
Model / Reference
SDK4450-FT FDA UDI
Description
Firm Tip; Endobronchial Procedure Kit;45 Catheter FDA UDI

Identifiers

Primary DI / UDI-DI
10884521545564 FDA UDI
FDA Product Code
JAK FDA UDI
GMDN Term
Bronchoscopic catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1750 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

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

Dimensions & Sizes

Size
Outer Diameter — 2.68 Millimeter FDA UDI
Length — 1069.5 Millimeter FDA UDI

Category: Bronchoscopic catheter

Edge by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bronchoscopic catheter.

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
Covidien LP

Sources (1)

  • FDA UDI fefff603-f4f6-404f-998a-e2c8a1096660 36 fields · synced May 30, 2026