Lok-Bar™

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref MTSBRT054Model Stereotactic Body Radiation Therapy (SBRT)

by Medtec LLC

Identity

Trade Name: Lok-Bar™ FDA UDI
Generic Name: Radiological whole-body positioner FDA UDI
Device Name: Lok-Bar™ (3-Pin) FDA UDI
Model / Reference: MTSBRT054 EUDAMEDFDA UDI
Stereotactic Body Radiation Therapy (SBRT) EUDAMED
Description: Lok-Bar™ (3-Pin) FDA UDI

Identifiers

Catalog Number: MTSBRT054 FDA UDI
Primary DI / UDI-DI: 00841439107485 EUDAMEDFDA UDI
Basic UDI-DI: 8414391OC0017R01BH EUDAMED
510(k) Number: K111340 FDA UDI
K973842 FDA UDI
FDA Product Code: IYE FDA UDI
IXQ FDA UDI
LNH FDA UDI
EMDN Code: Z12011299 PATIENT POSITIONING INSTRUMENTS – OTHER EUDAMED
GMDN Term: Radiological whole-body positioner FDA UDI

Classification

Device Class: Class I EUDAMED
Class II FDA UDI
Regulation Number: 892.5050 FDA UDI
892.1980 FDA UDI
892.1000 FDA UDI
Market of Registration: Netherlands EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Radiological whole-body positioner

Lok-Bar™ by Medtec LLC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Radiological whole-body positioner.

FoamSTEP Semiroll 400 x 220 x 220 Dm (H110) — IT-V Medizintechnik GmbH · Class II
iFRAME Head Double — IT-V Medizintechnik GmbH · Class II
Orfit Industries — Orfit Industries NV · Class II
BellySTEP Baseplate cut out long — IT-V Medizintechnik GmbH · Class II
iCAST Head US Maxi 2mm — IT-V Medizintechnik GmbH · Class II
iCAST H&S Micro 2mm — IT-V Medizintechnik GmbH · Class II
MCT Wedge Indexing Bar for Elekta — IT-V Medizintechnik GmbH · Class II
Orfit Industries — Orfit Industries NV · Class II

Cleared under the same submission

K111340 also covers:

K973842 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Medtec LLC

Sources (2)

FDA UDI 98b45d1e-b617-485e-a492-d87693893483 36 fields · synced Jul 12, 2026
EUDAMED da3a34f4-9e87-4ae9-929e-bfe4799ec374 61 fields · synced Jul 12, 2026