← Back to catalogue

Hercules

FDA UDI

Class I (US FDA UDI)

by Cook Incorporated

Identity

Trade Name
Hercules FDA UDI
Generic Name
Gastrointestinal/biliary dilation balloon catheter, non-medicated FDA UDI
Device Name
Hercules 100 Transnasal Esophageal Balloon FDA UDI
Model / Reference
G35267 FDA UDI
Description
Hercules 100 Transnasal Esophageal Balloon FDA UDI

Identifiers

Catalog Number
HBDE-W-8-9-10 FDA UDI
Primary DI / UDI-DI
00827002352674 FDA UDI
FDA Product Code
KCF FDA UDI
GMDN Term
Gastrointestinal/biliary dilation balloon catheter, non-medicated FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.4420 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: Gastrointestinal/biliary dilation balloon catheter, non-medicated

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

Similar devices

Also classified as Gastrointestinal/biliary dilation balloon catheter, non-medicated.

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
Cook Incorporated

Sources (1)

  • FDA UDI 8f1bf2b2-3b37-40e6-b3e5-6e09230e4b4c 36 fields · synced Jun 8, 2026