Nivo

FDA UDI

Class I (US FDA UDI)

by B. Ali Impex

Identity

Trade Name: Nivo FDA UDI
Generic Name: Dental excavator, reusable FDA UDI
Device Name: Excavator #17Spoon FDA UDI
Model / Reference: NEX17 FDA UDI
Description: Excavator #17Spoon FDA UDI

Identifiers

Primary DI / UDI-DI: 08964003163365 FDA UDI
FDA Product Code: EKC FDA UDI
GMDN Term: Dental excavator, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4565 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

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental excavator, reusable

Nivo by B. Ali Impex — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: B. Ali Impex

Sources (1)

FDA UDI 14b24353-3f3c-4b22-8c9e-261d9d54420b 33 fields · synced May 30, 2026