FDA.reportPublic FDA data

HS Bite Silicone Covers

Primary DI
09120074394506
Brand
HS Bite Silicone Covers
Company
IT-V Medizintechnik GmbH
Model
P10107-450
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081218000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081218000BELLYSTEP, HEADSTEP, BREASTSTEP, PROSTEP, WINGSTEP AND ICASTIt-V Medizintechnik, GmbH2008-07-21IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09120074394506PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09120074394506091200743945069120074394506

GMDN Terms#

Term, Definition table
TermDefinition
Radiological whole-body positionerA device comprised of fixed or adjustable position elements designed to ensure adequate positioning and/or immobilization of a patient's whole body during diagnostic imaging, image guided surgical or interventional procedures, and/or radiation therapy procedures; it may in addition be used to position a patient’s body part (however it is not dedicated to a specific part of the body). It is in the form of a frame, board, cushion, or preformed pad and may be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.

Regulatory Flags#

DUNS number
300005408
Device count
1
DM exempt
false
Premarket exempt
false
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
09120074394063HS Indexing AdapterP10107-4062016-09-01
09120074394339HS Indexing Adapter Elekta 530P10107-4332016-09-01
09120074397040System HeadSTEP MR glasfibreP10107-7042016-09-01
09120074394001HeadSTEP MR Basic ModuleP10107-4002016-09-01
09120074395176HS S-TYPE Basic Module MRP10107-5172018-04-16
09120074397194System HS S-TYPE MRP10107-7192018-04-16
09120074394490HS Bite Angulating Fixation Set WideP10107-4492016-09-01
09120074397910System HeadSTEP Bite WideP10107-7912016-09-01
09120074396364Wall holder for CT STEPP10107-6362016-09-01
09120074394018HeadSTEP IMRT MR Basic ModuleP10107-4012024-11-12
09120074395312WingSTEP high for Varian BaseplateP10107-5312024-11-12
09120074395329WingSTEP low for Varian BaseplateP10107-5322024-11-12
09120074395404BreastSTEP Short Mask Basic ModuleP10107-5402024-11-12
09120074395411BreastSTEP Long Mask Basic ModuleP10107-5412024-11-12
09120074395428BreastSTEP Short MR Basic ModuleP10107-4372024-11-12
09120074395435BreastSTEP Long MR Basic ModuleP10107-5432024-11-12
09120074391000HeadSTEP Carbon Basic ModuleP10107-1002016-09-01
09120074391017HeadSTEP Carbon Flat Basic ModuleP10107-1012016-09-01
09120074391604BellySTEP BaseplateP10107-1602016-09-01
09120074394025HeadSTEP iBEAM evo Extension Basic ModuleP10107-4022016-09-01

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Primary DI, Brand, Company table
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