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Instrapac

FDA UDI

Class I (US FDA UDI)

by Robinson Healthcare Limited

Identity

Trade Name
Instrapac FDA UDI
Generic Name
Manual dental burnisher, single-use FDA UDI
Device Name
Instrapac Ball Burnisher Double Ended X 40 FDA UDI
Model / Reference
7809 FDA UDI
Description
Instrapac Ball Burnisher Double Ended X 40 FDA UDI

Identifiers

Catalog Number
7809 FDA UDI
Primary DI / UDI-DI
05010058078093 FDA UDI
FDA Product Code
EKJ FDA UDI
GMDN Term
Manual dental burnisher, single-use 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

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

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Manual dental burnisher, single-use

Instrapac by Robinson Healthcare Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Manual dental burnisher, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Robinson Healthcare Limited

Sources (1)

  • FDA UDI f2ca0285-a74a-43f9-8196-6d9a3d55292b 36 fields · synced Jun 7, 2026