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AdvanCE

FDA UDI

Class II (US FDA UDI)

by US Endoscopy

Identity

Trade Name
AdvanCE FDA UDI
Generic Name
Video capsule endoscopy system capsule introducer FDA UDI
Device Name
The disposable AdvanCE capsule endoscope delivery device is a 2.5mm single sheathed device indicated for transendoscopic delivery of Capsules (with the dimensions of 10.5mm - 11.5mm in diameter and 23.5mm - 26.5mm in length), to the stomach or duodenum. This device is intended for patients who are either unable to swallow the capsule, or unable to pass the capsule beyond the pylorus in sufficient time to complete the desired diagnostic evaluation. FDA UDI
Model / Reference
00711144 FDA UDI
Description
The disposable AdvanCE capsule endoscope delivery device is a 2.5mm single sheathed device indicated for transendoscopic delivery of Capsules (with the dimensions of 10.5mm - 11.5mm in diameter and 23.5mm - 26.5mm in length), to the stomach or duodenum. This device is intended for patients who are either unable to swallow the capsule, or unable to pass the capsule beyond the pylorus in sufficient time to complete the desired diagnostic evaluation. FDA UDI

Identifiers

Catalog Number
00711144 FDA UDI
Primary DI / UDI-DI
00724995183608 FDA UDI
FDA Product Code
NEZ FDA UDI
GMDN Term
Video capsule endoscopy system capsule introducer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1300 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

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
Outer Diameter — 2.5 Millimeter FDA UDI
Length — 180 Centimeter FDA UDI

Category: Video capsule endoscopy system capsule introducer

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
US Endoscopy

Sources (1)

  • FDA UDI 4db4d90d-b32b-4f9c-be74-42a4a32cbb71 37 fields · synced Jun 8, 2026