Bone Tamp

FDA UDI

Class I (US FDA UDI)

by Sontec Instruments, Inc.

Identity

Trade Name: Bone Tamp FDA UDI
Generic Name: Orthopaedic osteotome FDA UDI
Device Name: Bone Tamp Hexagonal Handle 6.0 Millimeter X 10.0 Millimeter FDA UDI
Model / Reference: 335-404 FDA UDI
Description: Bone Tamp Hexagonal Handle 6.0 Millimeter X 10.0 Millimeter FDA UDI

Identifiers

Primary DI / UDI-DI: 00192896105607 FDA UDI
FDA Product Code: HWM FDA UDI
GMDN Term: Orthopaedic osteotome FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 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

Yes

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

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 10 Inch FDA UDI

Category: Orthopaedic osteotome

Bone Tamp by Sontec Instruments, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Sklar® — Sklar Corporation · 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: Sontec Instruments, Inc.

Sources (1)

FDA UDI cbd8ee6c-0f35-41b6-8211-65ad1cb7401f 35 fields · synced May 31, 2026