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Cook 810

FDA UDI

Class II (US FDA UDI)

by Cook Incorporated

Identity

Trade Name
Cook 810 FDA UDI
Generic Name
Endoscopic-access dilator, single-use FDA UDI
Device Name
Cook 810 Set FDA UDI
Model / Reference
G15079 FDA UDI
Description
Cook 810 Set FDA UDI

Identifiers

Catalog Number
030000-S1 FDA UDI
Primary DI / UDI-DI
00827002150799 FDA UDI
FDA Product Code
EZN FDA UDI
GMDN Term
Endoscopic-access dilator, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5470 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

Category: Endoscopic-access dilator, single-use

Cook 810 by Cook Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscopic-access dilator, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cook Incorporated

Sources (1)

  • FDA UDI 96430ba9-184b-44f9-a65c-d613541bfc88 36 fields · synced Jun 8, 2026