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Headpins

FDA UDI

Class II (US FDA UDI)

by Brainlab SE

Identity

Trade Name
Headpins FDA UDI
Generic Name
Stereotactic radiosurgical invasive head frame FDA UDI
Model / Reference
41561-8 FDA UDI

Identifiers

Catalog Number
41561-8 FDA UDI
Primary DI / UDI-DI
04056481003944 FDA UDI
510(k) Number
K954789 FDA UDI
FDA Product Code
HAW FDA UDI
GMDN Term
Stereotactic radiosurgical invasive head frame FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4560 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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Stereotactic radiosurgical invasive head frame

Headpins by Brainlab SE — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Stereotactic radiosurgical invasive head frame.

Cleared under the same submission

K954789 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Brainlab SE

Sources (1)

  • FDA UDI f9648e16-20f3-405d-abe6-3b7c18372d1b 35 fields · synced May 31, 2026