FDA.reportPublic FDA data

Solstice™ MR SRS Immobilization System

Primary DI
00841439113233
Brand
Solstice™ MR SRS Immobilization System
Company
MEDTEC, INC.
Model
CHS03MR
Catalog number
CHS03MR
Device description
Head support system for use with Posifix® systems
Published
2020-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYEAccelerator, linear, medical
LNHSystem, nuclear magnetic resonance imaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2
LNHSystem, Nuclear Magnetic Resonance ImagingRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182079000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182079000Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic MaskMedtec Inc. Dba Civco Medical Solutions2018-09-07IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841439113233PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841439113233008414391132338414391132330841439113233

GMDN Terms#

Term, Definition table
TermDefinition
Radiological headrestA non-sterile device intended to facilitate adequate positioning and immobilization of the patient's head and neck for reproducible positioning during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures. The device is in the form of a frame, cushion, or preformed pad that is intended to directly contact the head, and which may be customizable for single-patient use. This is a reusable device.

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
Lot or batch
true
Serial number
true
Manufacturing date on label
true

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00841439109748Fiducial Marker KitMTNW887840MTNW8878402017-08-02
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