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Rapid

FDA UDI

Class II (US FDA UDI)

by Given Imaging , Ltd.

Identity

Trade Name
RAPID FDA UDI
Generic Name
Video capsule endoscopy system antenna FDA UDI
Device Name
WS, Dell T3600 V8.3 US FDA UDI
Model / Reference
FGS-0576 FDA UDI
Description
WS, Dell T3600 V8.3 US FDA UDI

Identifiers

Primary DI / UDI-DI
07290101366041 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
Not 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Rapid by Given Imaging , Ltd. — 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

Sources (1)

  • FDA UDI 667e25d9-2a8e-4e4c-83d5-eb4a58f3e496 35 fields · synced May 30, 2026