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Headband Fixation L/XL

FDA UDI

Class II (US FDA UDI)

by Compumedics Germany GmbH

Identity

Trade Name
Headband Fixation L/XL FDA UDI
Generic Name
Noninvasive vascular ultrasound system probe FDA UDI
Device Name
Headband Set WITHOUT probes, size L/XL, bilateral FDA UDI
Model / Reference
Fix_Headband_L-XL_4038 FDA UDI
Description
Headband Set WITHOUT probes, size L/XL, bilateral FDA UDI

Identifiers

Catalog Number
4038 FDA UDI
Primary DI / UDI-DI
04260493311045 FDA UDI
510(k) Number
K051085 FDA UDI
FDA Product Code
ITX FDA UDI
GMDN Term
Noninvasive vascular ultrasound system probe FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1570 FDA UDI
Commercial Distribution
Not 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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Headband Fixation L/XL by Compumedics Germany GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K051085 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Compumedics Germany GmbH

Sources (1)

  • FDA UDI ffd47d31-7537-4495-95a8-e2b23cab0bab 37 fields · synced May 30, 2026