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Premier

FDA UDI

Class II (US FDA UDI)

by Premier Dental Products Company

Identity

Trade Name
Premier FDA UDI
Generic Name
General cryosurgical system, cryogen gas, mechanical FDA UDI
Device Name
NITROSPRAY PLUS (16oz) LOANER FDA UDI
Model / Reference
1006072 FDA UDI
Description
NITROSPRAY PLUS (16oz) LOANER FDA UDI

Identifiers

Primary DI / UDI-DI
D6911006072 FDA UDI
FDA Product Code
GEH FDA UDI
GMDN Term
General cryosurgical system, cryogen gas, mechanical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4350 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Liquid Chemical FDA UDI

Category: General cryosurgical system, cryogen gas, mechanical

Premier by Premier Dental Products Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General cryosurgical system, cryogen gas, mechanical.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Premier Dental Products Company

Sources (1)

  • FDA UDI 386aa360-66bb-4707-a221-a9da5bba4cdf 33 fields · synced May 31, 2026