PillCam

FDA UDI

Class II (US FDA UDI)

by Given Imaging , Ltd.

Identity

Trade Name: PillCam FDA UDI
Generic Name: Video capsule endoscopy system antenna FDA UDI
Device Name: PillCam™ sensor belt, SB Refurbished FDA UDI
Model / Reference: RFB-0590 FDA UDI
Description: PillCam™ sensor belt, SB Refurbished FDA UDI

Identifiers

Primary DI / UDI-DI: 07290110361334 FDA UDI
FDA Product Code: NEZ FDA UDI
GMDN Term: Video capsule endoscopy system antenna 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Video capsule endoscopy system antenna

PillCam by Given Imaging , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Video capsule endoscopy system antenna.

LEAD ANTENNA UNIT — Olympus Medical Systems Corporation · Class II
ANTENNA UNIT — Olympus Medical Systems Corporation · Class II
PillCam — Given Imaging , Ltd. · Class II
PillCam — Given Imaging , Ltd. · Class II
PillCam — Given Imaging , Ltd. · Class II
Pillcam — Given Imaging , Ltd. · Class II
Pillcam — Given Imaging , Ltd. · Class II
Pillcam — Given Imaging , Ltd. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Given Imaging , Ltd.

Sources (1)

FDA UDI cc205f9c-9600-498e-8d91-f0b76a7a5442 34 fields · synced May 31, 2026