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Brasseler USA

FDA UDI

Class II (US FDA UDI)

by Peter Brasseler Holdings, LLC

Identity

Trade Name
Brasseler USA FDA UDI
Generic Name
Bone/joint surgical power tool motorized handpiece/set, pneumatic FDA UDI
Device Name
KM-A90-201 FDA UDI
Model / Reference
KM-A90-201 FDA UDI
Description
KM-A90-201 FDA UDI

Identifiers

Primary DI / UDI-DI
00887919489603 FDA UDI
510(k) Number
K030172 FDA UDI
FDA Product Code
HBE FDA UDI
GMDN Term
Bone/joint surgical power tool motorized handpiece/set, pneumatic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4310 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Bone/joint surgical power tool motorized handpiece/set, pneumatic

Brasseler USA by Peter Brasseler Holdings, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone/joint surgical power tool motorized handpiece/set, pneumatic.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Peter Brasseler Holdings, LLC

Sources (1)

  • FDA UDI 94486c68-5383-4198-8406-1ed7b39b0351 34 fields · synced May 30, 2026