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Articulator

FDA UDI

Class II (US FDA UDI)

by US Endoscopy

Identity

Trade Name
Articulator FDA UDI
Generic Name
General-purpose endoscopic needle, single-use FDA UDI
Device Name
The Articulator injection needle is a single use, disposable, flexible sheath injection needle used for the injection of various types of media through flexible endoscopes. FDA UDI
Model / Reference
00711803 FDA UDI
Description
The Articulator injection needle is a single use, disposable, flexible sheath injection needle used for the injection of various types of media through flexible endoscopes. FDA UDI

Identifiers

Catalog Number
00711803 FDA UDI
Primary DI / UDI-DI
00724995180836 FDA UDI
FDA Product Code
FCG FDA UDI
GMDN Term
General-purpose endoscopic needle, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1075 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

Dimensions & Sizes

Size
Needle Gauge — 25 Gauge FDA UDI
Outer Diameter — 2.5 Millimeter FDA UDI
Length — 160 Centimeter FDA UDI

Category: General-purpose endoscopic needle, single-use

Articulator by US Endoscopy — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General-purpose endoscopic needle, 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 7d16071b-f142-4636-a2cd-a8de4196de7e 37 fields · synced May 30, 2026