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Echotip

FDA UDI

Class II (US FDA UDI)

by Cook Incorporated

Identity

Trade Name
Echotip FDA UDI
Generic Name
Nephrostomy catheter introduction needle FDA UDI
Device Name
Echotip, Disposable Two-Part Trocar Needle FDA UDI
Model / Reference
G15621 FDA UDI
Description
Echotip, Disposable Two-Part Trocar Needle FDA UDI

Identifiers

Catalog Number
090021-ET FDA UDI
Primary DI / UDI-DI
00827002156210 FDA UDI
FDA Product Code
FBQ FDA UDI
GMDN Term
Nephrostomy catheter introduction needle FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5090 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

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: Nephrostomy catheter introduction needle

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

Similar devices

Also classified as Nephrostomy catheter introduction needle.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cook Incorporated

Sources (1)

  • FDA UDI 3fd07960-aab0-4c6d-92a7-b1e328b1c94e 36 fields · synced Jun 6, 2026