Sklar

FDA UDI

Class I (US FDA UDI)

by Sklar Corporation

Identity

Trade Name: Sklar FDA UDI
Generic Name: Periosteal elevator, reusable FDA UDI
Device Name: KRALLENHEBER ROOT ELEVATOR SIZE 1 FDA UDI
Model / Reference: 49-8617 FDA UDI
Description: KRALLENHEBER ROOT ELEVATOR SIZE 1 FDA UDI

Identifiers

Primary DI / UDI-DI: 10649111444272 FDA UDI
FDA Product Code: EMJ FDA UDI
GMDN Term: Periosteal elevator, 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

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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Periosteal elevator, reusable

Sklar by Sklar Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Periosteal elevator, reusable.

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SCANLAN® Instrumentation — SCANLAN INTERNATIONAL INC · Class I
BARRIER PLACEMENT INSTRUMENT — W.H. Holden, Inc. · Class I
ELEVATOR — KLS-Martin L.P. · Class I
HELMUT ZEPF — Helmut Zepf Medizintechnik GmbH · Class I
Ambler Surgical — Ambler Surgical, LLC · Class I

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: Sklar Corporation

Sources (1)

FDA UDI 463b7811-9d6f-4828-ab7c-c7c49487fd6b 33 fields · synced May 30, 2026