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Instrapac

FDA UDI

Class I (US FDA UDI)

by Robinson Healthcare Limited

Identity

Trade Name
Instrapac FDA UDI
Generic Name
Periosteal elevator, single-use FDA UDI
Device Name
Instrapac Periosteal Elevator No.1 x 10 FDA UDI
Model / Reference
8133 FDA UDI
Description
Instrapac Periosteal Elevator No.1 x 10 FDA UDI

Identifiers

Catalog Number
8133 FDA UDI
Primary DI / UDI-DI
05010058081338 FDA UDI
FDA Product Code
EMJ FDA UDI
GMDN Term
Periosteal elevator, 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: Periosteal elevator, single-use

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

Similar devices

Also classified as Periosteal elevator, 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 d55884dc-69b0-49b1-ac4c-e623f899155c 36 fields · synced May 30, 2026