FDA.reportPublic FDA data

Prone Head Holder

Primary DI
00841439102466
Brand
Prone Head Holder
Company
MEDTEC, INC.
Model
MT202
Catalog number
MT202
Device description
with gel pads (2)
Published
2017-08-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
IWYHolder, head, radiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWYHolder, Head, RadiographicRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841439102466PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841439102466008414391024668414391024660841439102466

GMDN Terms#

Term, Definition table
TermDefinition
Patient positioner base plateA device in the form of a flat plate/bar intended to be attached to an operating/radiological table to function as a supportive foundation to which patient positioning devices can be attached (e.g., arch frame, thermoplastic mask, headrest, head positioner). It is used to facilitate positioning and immobilization of a patient’s body part during intraoperative procedures (e.g., orthopaedic surgery), or radiological procedures that require reproducible positioning [e.g., serial imaging studies, radiation treatment planning, radiation therapy procedures or stereotactic radiotherapy (SRT) and stereotactic radiosurgery (SRS)]. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length12Inch
Width10Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(712)737-8688radiotherapy.complaints@civcort.com

Regulatory Flags#

DUNS number
103977526
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841439115152Upright Arm Positioner RT-4900RT-49002026-01-08
00841439114650PronumbraRT-4536-HH01LRT-4536-HH01L2025-09-12
00841439114674PronumbraRT-4536-HH01RRT-4536-HH01R2025-09-12
00841439114681PronumbraRT-4536KV-01RT-4536KV-012025-09-12
00841439114698PronumbraRT-4536-NS40RT-4536-NS402025-09-12
00841439114704PronumbraRT-4536-NS50RT-4536-NS502025-09-12
00841439114711PronumbraRT-4536-NS65RT-4536-NS652025-09-12
00841439114728PronumbraRT-4536-SA01RT-4536-SA012025-09-12
00841439114841ZiFix TraverseRT-4558CB04RT-4558CB042025-09-12
00841439114995PronumbraRT-4536KV-02RT-4536KV-022025-09-12
00841439115008PronumbraRT-4536-01RT-4536-012025-09-12
00841439115084ONEFitRT-4800-C0RT-4800-C02025-09-12
00841439115091Encompass™RT-B889KYSHRT-B889KYSH2025-09-12
00841439115107Encompass™RT-B889KYSH-1RT-B889KYSH-12025-09-12
00841439115121PronumbraRT-4536-100RT-4536-1002025-09-12
00841439115138PronumbraRT-4536KV-200RT-4536KV-2002025-09-12
10841439114732PronumbraRT-C876KRT-C876K2025-09-12
10841439114749PronumbraRT-C878KRT-C878K2025-09-12
10841439114770PronumbraRT-C889KRT-C889K2025-09-12
10841439114787PronumbraRT-C892KRT-C892K2025-09-12

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