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Hibbs Osteotome

FDA UDI

Class I (US FDA UDI)

by Sontec Instruments, Inc.

Identity

Trade Name
HIBBS OSTEOTOME FDA UDI
Generic Name
Orthopaedic osteotome FDA UDI
Device Name
HIBBS OSTEOTOME CURVED TIP FDA UDI
Model / Reference
330-570 FDA UDI
Description
HIBBS OSTEOTOME CURVED TIP FDA UDI

Identifiers

Catalog Number
330-570 FDA UDI
Primary DI / UDI-DI
00192896029880 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

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Width — 0.25 Inch FDA UDI
Length — 9.5 Inch FDA UDI

Category: Orthopaedic osteotome

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

Similar devices

Also classified as Orthopaedic osteotome.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sontec Instruments, Inc.

Sources (1)

  • FDA UDI 19d8d72f-84d1-4138-86cb-9d86c8375884 36 fields · synced Jun 8, 2026