FDA.report

N/A

Primary DI
04961333242191
Brand
N/A
Company
PENTAX OF AMERICA, INC.
Model
9200D
Device description
DIGITAL VIDEO CAPTURE MODULE
Published
2018-03-08
Public version status
New
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
OUGMedical Device Data System

Product Code Classifications

CodeDeviceSpecialtyClass
OUGMedical Device Data SystemGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04961333242191PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04961333242191049613332421914961333242191

GMDN Terms

TermDefinition
Video cassette recorderA mains electricity (AC-powered), electronic, device designed to receive and store both image and sound on a magnetic video tape (a standard video cassette) as electronic signals. During recording, the inputs of the recorder's electronic circuitry and recording heads are connected to a video signal source (e.g., video or television camera). The information is retrieved through playback heads (that typically are an integral part of the recorder), and the output is connected to an appropriate monitor or is fed into another device for further manipulation. This is a general-purpose recording/playback device and is commonly called a VCR (video cassette recorder).

Sterilization Methods

Method

Regulatory Flags

DUNS number
083211284
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
04961333255696Digital Capture v3.7.09380 2025-09-12
04961333255979 MICROPHONE ASSAY KIT6651 2025-07-21
04961333255986Disposables Kit6650 2025-07-21
04961333255016LARYNGOSTROBOSCOPE95002025-04-25
04961333255702LARYNGOSTROBOSCOPE9500LX2025-04-25
04961333255719LARYNGOSTROBOSCOPE9500MC2025-04-25
04961333255726LARYNGOSTROBOSCOPE9500FS2025-04-25
00854924006255C2 CryoBalloon Ablation System FG-10252025-04-04
00854924006293C2 CryoBalloon Ablation SystemFG-10292025-04-04
04961333255313C2 CryoBalloonFG-10552024-09-12
04961333255320C2 CryoBalloonFG-10562024-09-12
04961333254309MULTI-SPEECH3706-12023-08-25
04961333248117Pentax of America93802022-11-04
04961333248445C2 CryoBalloon NitroclipFG-10502020-08-07
00854924006408C2 CryoBalloon EndoGripFG-10402020-07-29
04961333248001ENDOPRO REVIEW WORKSTATIONKBM68344NA2020-03-26
04961333248018ENDOPRO NETWORK CAPTURE WORKSTATIONKBM683452020-03-26
04961333248025ENDOPRO STANDALONEC CAPTURE WORKSTATIONKBM683462020-03-26
04961333244355BRANDMAXU-5LH2018-03-15
04961333244188N/AOS-H52018-03-15

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00199150006038N/AMEDTRONIC, INC.OUG2026-05-23
05404028001158Mimics FlowMaterialise NVOUG2026-03-23
05404028001172SurgiCase OnlineMaterialise NVOUG2026-03-23
05404028001189ProPlan CMF Materialise NVOUG2026-03-23
00763000994914NAMEDTRONIC, INC.OUG2026-03-22
00382904450106BD Veritor™ InfoWiFi ModuleBECTON, DICKINSON AND COMPANYOUG2026-03-13
04035479189211PatientApp 2.9BIOTRONIK SE & Co. KGOUG2026-03-04
07350149360033PD Care SystemPainDrainer ABOUG2026-03-04
00860015454706RocotoRocoto Inc.OUG2026-02-26
00860015454713RocotoRocoto Inc.OUG2026-02-26
00860015454720RocotoRocoto Inc.OUG2026-02-26
00860015454737RocotoRocoto Inc.OUG2026-02-26
00860015454768RocotoRocoto Inc.OUG2026-02-26
00860015454775RocotoRocoto Inc.OUG2026-02-26
00840241600412Kestra Provided Device Patient ApplicationKestra Medical Technologies, Inc.OUG2026-02-04
00199150002184NAMEDTRONIC, INC.OUG2026-02-01
03770034761006LIMSTARHOPI MEDICALOUG2026-01-28
03770034761013MINILIMHOPI MEDICALOUG2026-01-28
03770034761020FMCHOPI MEDICALOUG2026-01-28
03770034761037HOPACKHOPI MEDICALOUG2026-01-28
03770034761044SATCHELHOPI MEDICALOUG2026-01-28
05056190500658SafeIDVISION RT LIMITEDOUG2025-12-23
00850064210286ANNE Link MobileSibel Health Inc.OUG2025-12-11
15099590799243MicroScanBeckman Coulter, Inc.OUG2025-12-08
15099590799250MicroScanBeckman Coulter, Inc.OUG2025-12-08
15099590807146MicroScanBeckman Coulter, Inc.OUG2025-12-08
00199284197749ActuviActuvi LLCOUG2025-12-02
04260658860234myoncareONCARE GmbHOUG2025-11-26
07350149360026PD Care SystemPainDrainer ABOUG2025-11-13
04961333255696Digital Capture v3.7.0PENTAX OF AMERICA, INC.OUG2025-09-12