FDA.report

Connexion

Primary DI
04056719001247
Brand
Connexion
Company
Medical Intelligence Medizintechnik GmbH
Model
P10105-251
Catalog number
P10105-251
Device description
The Indexing Bridges are required in order to use the BodyFIX® 14 Target Positioner together with the Connexion™ Lateral Opening Module for SBRT.
Published
2016-08-23
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

Related Records

Product Codes

CodeName
IXQTable, Radiographic, Stationary Top

Product Code Classifications

CodeDeviceSpecialtyClass
IXQTable, Radiographic, Stationary TopRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04056719001247PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04056719001247040567190012474056719001247

GMDN Terms

TermDefinition
Accelerator system table, non-poweredA non-electrical radiotherapy device that is a component of an accelerator system specifically designed to position and support a patient, typically supine, during therapeutic radiation treatments administered using a medical linear accelerator or non-linear accelerator. It is a flat surface on legs with fixed position top or mechanical top positioning and/or height controls (e.g., pneumatic controls, magnetic locks, cranks and lever mechanisms). It may be an independent device that is stationary or mobile, or it can be an integral component of a medical accelerator system design.

Sterilization Methods

Method

Regulatory Flags

DUNS number
314546664
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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 DIBrandModelCatalogPublished
04056719002251iBEAMP10105-184P10105-1842022-07-12
04056719002190iGUIDE®P10603-111-223P10603-1112019-08-01
04056719002244HexaPODP10603-300P10603-3002021-09-28
04056719002213iBEAM®P10105-3002020-08-20
04056719002237iBEAM®P10105-1832020-07-07
04056719002060Fraxion™P10106-3002018-10-29
04056719002077Fraxion™ P10106-3012018-10-29
04056719002084Fraxion™ P10106-3022018-10-29
04056719002039iGUIDEP10603-111P10603-1112017-10-13
04056719000301BodyFIXP10102-408 P10102-408 2016-08-23
04056719001360FraxionP10106-101 P10106-101 2016-08-23
04056719001377FraxionP10106-102 P10106-102 2016-08-23
04056719001384FraxionP10106-103 P10106-103 2016-08-23
04056719001391FraxionP10106-104 P10106-104 2016-08-23
04056719001407FraxionP10106-110P10106-1102016-08-23
04056719001414FraxionP10106-111P10106-1112016-08-23
04056719001421FraxionP10106-113P10106-1132016-08-23
04056719001438FraxionP10106-114P10106-1142016-08-23
04056719001445FraxionP10106-115P10106-1152016-08-23
04056719001452FraxionP10106-120 P10106-120 2016-08-23

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