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Osteotome, 12.5cm WL

FDA UDI

Class I (US FDA UDI)

by Mizuho America, Inc.

Identity

Trade Name
Osteotome, 12.5cm WL FDA UDI
Generic Name
Plastic surgery osteotome FDA UDI
Device Name
Osteotome FDA UDI
Model / Reference
07-819-01 FDA UDI
Description
Osteotome FDA UDI

Identifiers

Primary DI / UDI-DI
00810009461029 FDA UDI
FDA Product Code
MDM FDA UDI
GMDN Term
Plastic surgery 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

No

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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Plastic surgery osteotome

Osteotome, 12.5cm WL by Mizuho America, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Plastic surgery osteotome.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mizuho America, Inc.

Sources (1)

  • FDA UDI b1c2c268-b2e8-4fd2-ae97-5c0ab42acf1f 33 fields · synced May 31, 2026