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PillCam

FDA UDI

Class II (US FDA UDI)

by Given Imaging , Ltd.

Identity

Trade Name
PillCam FDA UDI
Generic Name
Video capsule endoscopy system application software FDA UDI
Device Name
PillCam™ Recorder DR3 SW upgrade FDA UDI
Model / Reference
FGS-0664 FDA UDI
Description
PillCam™ Recorder DR3 SW upgrade FDA UDI

Identifiers

Primary DI / UDI-DI
07290110360719 FDA UDI
FDA Product Code
NEZ FDA UDI
GMDN Term
Video capsule endoscopy system application software 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

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Video capsule endoscopy system application software

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 application software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Given Imaging , Ltd.

Sources (1)

  • FDA UDI faa5f256-78be-4a56-a6e2-eabc51ddaccd 34 fields · synced Jun 8, 2026