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Pinnacle Complete LED Curing Light Sleeve

FDA UDI

Class II (US FDA UDI)

by Metrex Research

Identity

Trade Name
Pinnacle Complete LED Curing Light Sleeve FDA UDI
Generic Name
Instrument/equipment drape, single-use, non-sterile FDA UDI
Device Name
One Piece Design Covers the Tip as well as the Gun Handle FDA UDI
Model / Reference
LED250C FDA UDI
Description
One Piece Design Covers the Tip as well as the Gun Handle FDA UDI

Identifiers

Primary DI / UDI-DI
00615375004753 FDA UDI
FDA Product Code
MMP FDA UDI
GMDN Term
Instrument/equipment drape, single-use, non-sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4370 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Instrument/equipment drape, single-use, non-sterile

Pinnacle Complete LED Curing Light Sleeve by Metrex Research — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Instrument/equipment drape, single-use, non-sterile.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Metrex Research

Sources (1)

  • FDA UDI 7f162d42-0533-474d-a774-5c48be5af329 34 fields · synced May 31, 2026