Rocoto

Primary DI
00860015454775
Brand
Rocoto
Company
Rocoto Inc.
Model
MD52 Rx - MDWL2_B3P1RX
Published
2026-02-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
00860015454775PrimaryGS10

GMDN Terms

TermDefinition
Medical image management systemA computerized image data management system designed to electronically receive, collect, store, and display a broad range of medical imaging/video data (non-dedicated), and to distribute the data within or between healthcare facilities to facilitate data analysis, organization, reporting, and sharing (e.g., teaching). The system consists of combined hardware (e.g., network switch, controller) and server/client software intended to relay image data from a broad range of imaging/audiovisual devices (e.g., endoscopic camera, ultrasound imaging system, radiography digital imaging system) to off-the-shelf devices [e.g., monitors, personal computers (PC’s)].

Sterilization Methods

Method

Regulatory Flags

DUNS number
960475866
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
00860015454706RocotoMD62 Tx Device - MDWL2_B1J1TX2026-02-26
00860015454713RocotoMD62 Rx Device - MDWL2_B1J1RX2026-02-26
00860015454720RocotoMD11 Tx device - MDWL1_C1N1TX2026-02-26
00860015454737RocotoMD11 Rx device - MDWL1_B1J1RX2026-02-26
00860015454744RocotoSL11 device - Wireless Camera - MDMP1_SL11_1STE122026-02-26
00860015454751RocotoSL11 device Sterilizable Cover - AMN_ASM_10302026-02-26
00860015454768RocotoMD52 Tx - MDWL2_B1P1TX2026-02-26
00860015454782RocotoHM11 Device - MDWL1_HM112026-02-26
00860014100604AmimonMD62 Tx device - MDWL2_B1J1TXMDWL2_B1J1TX2025-06-24
00860014100611AmimonMD62 Rx device - MDWL2_B1J1RX MDWL2_B1J1RX2025-06-24
00860014100628AmimonMD11 Tx device - MDWL1_C1N1TXMDWL1_C1N1TX2025-06-24
00860014100635AmimonMD11 Rx device - MDWL1_B1N1RXMDWL1_B1N1RX2025-06-24
00860014100642AmimonSL11 device - Wireless Camera - MDMP1_SL11_1STE12MDMP1_SL11_1STE122025-06-24
00860014100659AmimonSL11 Sterilizable Cover - AMN_ASM_1030AMN_ASM_10302025-06-24
00860014100666AmimonMD52 Tx device - MDWL2_B1P1TXMDWL2_B1P1TX2025-06-24
00860014100673AmimonMD52 Rx device - MDWL2_B3P1RXMDWL2_B3P1RX2025-06-24
00860014100680AmimonHM11 Device - MDWL1_HM11MDWL1_HM112025-06-24

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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
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
00763000274559N/AMEDTRONIC, INC.OUG2025-09-05
04260657690726MLC-SADLINK Technology GmbHOUG2025-08-31