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Cook

FDA UDI

Class I (US FDA UDI)

by Cook Incorporated

Identity

Trade Name
Cook FDA UDI
Generic Name
Endoscopic cyst-aspiration set FDA UDI
Device Name
Topel Endoscopic Cyst Aspiration Needle FDA UDI
Model / Reference
G16590 FDA UDI
Description
Topel Endoscopic Cyst Aspiration Needle FDA UDI

Identifiers

Catalog Number
J-SDN-143940 FDA UDI
Primary DI / UDI-DI
00827002165908 FDA UDI
FDA Product Code
GAA FDA UDI
GMDN Term
Endoscopic cyst-aspiration set FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 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: Endoscopic cyst-aspiration set

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

Similar devices

Also classified as Endoscopic cyst-aspiration set.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cook Incorporated

Sources (1)

  • FDA UDI 8d1633a7-fe93-490c-b1d7-352b07d0bde2 36 fields · synced Jun 8, 2026