FDA.reportPublic FDA data

CC13 Ion chamber

Primary DI
EIBADS021001
Brand
CC13 Ion chamber
Company
IBA Dosimetry GmbH
Model
DS02-100
Device description
CC13 Ion chamber: 0.13 ccm, shonka plastic, waterproof, BNC triax
Published
2016-09-09
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EIBADS021001PackageHIBCC1In Commercial Distribution
EIBADS021000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiation electrometerA stand-alone external measuring device with a detection circuit that can be used with different ion chamber probes for conducting dosimetry measurements in high radiation fields. An electrometer typically includes output read out capabilities in charge, current, time, dose and dose rate.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49912860738service@iba-group.com

Regulatory Flags#

DUNS number
332599307
Device count
1
DM exempt
false
Premarket exempt
false
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

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EIBAHA050100Water ReservoirHA05-010HA05-0102023-08-03
EIBAE30702000myQA SRS Detector Cyberknife editionE3070200SR01-1002023-07-25
EIBAE30702001myQA SRS Detector Cyberknife editionE3070200SR01-1002023-07-25
EIBAE20702000DOSE-XE2070200DX00-0002023-04-13
EIBAE20703000DOSE-XE2070300DX00-1002023-04-13
EIBABS505000miniPhantomBS50-500BS50-5002023-04-12
EIBABS505001miniPhantomBS50-500BS50-5002023-04-12
EIBAE14000300CCU Steuerelektronik PTE14000302023-04-12
EIBAHA031150Lift tableHA03-115HA03-1152023-04-12
EIBAHA032300Lift tableHA03-230HA03-2302023-04-12
EIBAE30350100"CQA ""StarTrack"""E3035010BS80-000, BS80-010, BS80-1002016-09-09
EIBAM98000000IMRT - Bodyphantom M9800000BS40-0002016-09-09
EIBA120104HSE0KermaX-plus1120-104 HS E2021-12-17
EIBA120104HST0KermaX-plus1120-104 HS T2021-12-17

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