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Double-Header

FDA UDI

Class I (US FDA UDI)

by US Endoscopy

Identity

Trade Name
Double-Header FDA UDI
Generic Name
Surgical instrument/endoscope cleaning utensil, single-use FDA UDI
Device Name
The Double Header Channel and Control Head Combo is a channel cleaning brush with nylon Flexi Brush attached to a flexible plastic sheath designed to safely remove debris from from the valve openings and dials of the control head of flexible endoscopes. FDA UDI
Model / Reference
00711609 FDA UDI
Description
The Double Header Channel and Control Head Combo is a channel cleaning brush with nylon Flexi Brush attached to a flexible plastic sheath designed to safely remove debris from from the valve openings and dials of the control head of flexible endoscopes. FDA UDI

Identifiers

Catalog Number
00711609 FDA UDI
Primary DI / UDI-DI
00724995184971 FDA UDI
FDA Product Code
MNL FDA UDI
GMDN Term
Surgical instrument/endoscope cleaning utensil, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
876.1500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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: Surgical instrument/endoscope cleaning utensil, single-use

Double-Header by US Endoscopy — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical instrument/endoscope cleaning utensil, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
US Endoscopy

Sources (1)

  • FDA UDI 38fc8733-f4c5-47c6-8270-3325e45f6b3b 35 fields · synced Jun 1, 2026