Patient Hand Grip

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref MTSBRT0051Model Stereotactic Body Radiation Therapy (SBRT)

by Medtec LLC

Identity

Trade Name: Patient Hand Grip FDA UDI
Generic Name: Radiological whole-body positioner FDA UDI
Device Name: Patient Hand Grip - Left FDA UDI
Model / Reference: MTSBRT0051 EUDAMEDFDA UDI
Stereotactic Body Radiation Therapy (SBRT) EUDAMED
Description: Patient Hand Grip - Left FDA UDI

Identifiers

Catalog Number: MTSBRT0051 FDA UDI
Primary DI / UDI-DI: 00841439107287 EUDAMEDFDA UDI
Basic UDI-DI: 8414391OC0017R01BH EUDAMED
510(k) Number: K111340 FDA UDI
K973842 FDA UDI
FDA Product Code: LNH FDA UDI
IXQ FDA UDI
IYE 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: 892.1000 FDA UDI
892.1980 FDA UDI
892.5050 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

Dimensions & Sizes

Size: Width — 3.1 Inch FDA UDI
Length — 7.6 Inch FDA UDI

Category: Radiological whole-body positioner

Patient Hand Grip by Medtec LLC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

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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

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Manufacturer

Manufacturer: Medtec LLC

Sources (2)

FDA UDI 7a0fdfde-bfad-428f-b4bf-9808a07c477c 37 fields · synced Jul 31, 2026
EUDAMED 496f66eb-a997-40f7-a2b3-77bd4131c0be 61 fields · synced Jul 31, 2026