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Nucleotome

FDA UDI

Class I (US FDA UDI)

by Clarus Medical, Llc

Identity

Trade Name
Nucleotome FDA UDI
Generic Name
Surgical power tool system control unit, pneumatic FDA UDI
Device Name
Nucleotome Console FDA UDI
Model / Reference
11000 FDA UDI
Description
Nucleotome Console FDA UDI

Identifiers

Catalog Number
11000 FDA UDI
Primary DI / UDI-DI
B067110000 FDA UDI
510(k) Number
K844131 FDA UDI
FDA Product Code
HSZ FDA UDI
GMDN Term
Surgical power tool system control unit, pneumatic FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4820 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Surgical power tool system control unit, pneumatic

Nucleotome by Clarus Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical power tool system control unit, pneumatic.

Cleared under the same submission

K844131 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Clarus Medical, Llc

Sources (1)

  • FDA UDI d40491a8-7ed4-4a3f-b3ee-546fe4ea3d7b 37 fields · synced May 31, 2026