FDA.report

Prone Shell

Primary DI
00841439102473
Brand
Prone Shell
Company
MEDTEC, INC.
Model
MT20215
Catalog number
MT20215
Device description
Reusable non-sterile Vac-Lok™ interface with extension hose
Published
2017-08-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
IWYHolder, head, radiographic

Product Code Classifications

CodeDeviceSpecialtyClass
IWYHolder, Head, RadiographicRadiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841439102473PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841439102473008414391024738414391024730841439102473

GMDN Terms

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

TypeValueUnit
Length26.4Centimeter
Width14Centimeter

Sterilization Methods

Method

Contacts

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

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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
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