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Habib

FDA UDI

Class II (US FDA UDI)

by Navilyst Medical, Inc.

Identity

Trade Name
Habib FDA UDI
Generic Name
Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar FDA UDI
Device Name
RITA Habib 4X Laparoscopic Electrosurgical Device FDA UDI
Model / Reference
700-103659 FDA UDI
Description
RITA Habib 4X Laparoscopic Electrosurgical Device FDA UDI

Identifiers

Primary DI / UDI-DI
H7877001036591 FDA UDI
510(k) Number
K062935 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4400 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

No

FDA UDI

Category: Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar

Habib by Navilyst Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Navilyst Medical, Inc.

Sources (1)

  • FDA UDI 001470c2-6c57-40e0-8a6f-f5b3ea6d6dee 35 fields · synced May 29, 2026