FDA.report

FLEX

Primary DI
08308501900044
Brand
FLEX
Company
MEDROBOTICS CORPORATION
Model
26470
Device description
TA Case Kit 1
Published
2019-04-01
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
true

Related Records

Product Codes

CodeName
FDFColonoscope And Accessories, Flexible/Rigid

Product Code Classifications

CodeDeviceSpecialtyClass
FDFColonoscope And Accessories, Flexible/RigidGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08308501900044PreviousGS10
00850190004834PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
08308501900044083085019000448308501900044
00850190004834008501900048348501900048340850190004834

GMDN Terms

TermDefinition
Robotic surgical systemAn assembly of electromechanical devices typically used during orthopaedic computer assisted surgery (CAS) as a functional extension of the surgeon for precise bone and soft-tissue modelling or soft-tissue removal (e.g., during a total knee joint arthroplasty (TKA)). It is computer-based and typically consists of, e.g., an operator console and arms for instrument manipulation. The input to a computer is usually by means of an existing computed tomography (CT) or magnetic resonance imaging (MRI) scan. It can also be used as a training aid for surgeons from a variety of specialities.

Sterilization Methods

Method

Regulatory Flags

DUNS number
002764627
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
true
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
00850190004018FLEX229952019-10-30
00850190004025FLEX246982019-10-30
00850190004032FLEX246992019-10-30
00850190004049FLEX243242018-12-07
00850190004063FLEX501522019-10-30
00850190004070FLEX231572019-10-30
00850190004087FLEX234982019-07-01
00850190004094FLEX233922019-10-30
00850190004100Flex251712019-07-01
00850190004117Flex254632019-05-07
00850190004124Flex251732019-07-01
00850190004131FLEX251782019-07-01
00850190004155Flex24324-L2019-04-30
00850190004162FLEX500832019-01-07
00850190004209FLEX500792019-01-07
00850190004247FLEX50074PKG2019-10-30
00850190004254FLEX50134PKG2019-10-30
00850190004261FLEX50137PKG2019-10-30
00850190004285FLEX50147PKG2019-10-30
00850190004292FLEX50149PKG2019-10-30

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
04953170467349ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UE160-AL5OLYMPUS MEDICAL SYSTEMS CORP.FDF2025-09-25
14547410477242FUJIFILMFUJIFILM CORPORATIONFDF2025-06-30
14547410477273FUJIFILMFUJIFILM CORPORATIONFDF2025-06-30
14547410477303FUJIFILMFUJIFILM CORPORATIONFDF2025-06-30
04953170425103COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.FDF2025-05-26
04953170425158COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.FDF2025-05-26
04961333356478PENTAX MedicalHOYA CORPORATIONFDF2025-04-28
04961333129430PENTAXHOYA CORPORATIONFDF2025-04-04
04961333172085PENTAXHOYA CORPORATIONFDF2025-04-04
84953170463910BALLOON3OLYMPUS MEDICAL SYSTEMS CORP.FDF2025-02-25
00850458007041GripTract-GI Endoscopic Tissue ManipulatorACTUATED MEDICAL, INC.FDF2025-01-16
04961333254620PENTAX MedicalHOYA CORPORATIONFDF2024-12-13
04953170465970EVIS EXERA III XENON LIGHT SOURCEOLYMPUS MEDICAL SYSTEMS CORP.FDF2024-11-25
06972520301094REDPINEGuangzhou Red Pine Medical Instrument Co., Ltd.FDF2024-09-02
06972520301100REDPINEGuangzhou Red Pine Medical Instrument Co., Ltd.FDF2024-09-02
06972520301117REDPINEGuangzhou Red Pine Medical Instrument Co., Ltd.FDF2024-09-02
06972520301124REDPINEGuangzhou Red Pine Medical Instrument Co., Ltd.FDF2024-09-02
06972520301179REDPINEGuangzhou Red Pine Medical Instrument Co., Ltd.FDF2024-09-02
06972520301186REDPINEGuangzhou Red Pine Medical Instrument Co., Ltd.FDF2024-09-02
06972520301193REDPINEGuangzhou Red Pine Medical Instrument Co., Ltd.FDF2024-09-02
06972520301209REDPINEGuangzhou Red Pine Medical Instrument Co., Ltd.FDF2024-09-02
04961333254781PENTAXHOYA CORPORATIONFDF2024-07-26
04961333254460PENTAXHOYA CORPORATIONFDF2024-07-26
04961333254811PENTAXHOYA CORPORATIONFDF2024-07-26
04961333254477PENTAXHOYA CORPORATIONFDF2024-07-26
04961333254798PENTAXHOYA CORPORATIONFDF2024-07-26
50724995228939DEFENDOMEDIVATORS INC.FDF2024-01-18
B369MES01019MEDISONOMedisono, LLCFDF2023-11-17
B369MES01020MEDISONOMedisono, LLCFDF2023-11-17
B369MES01021MEDISONOMedisono, LLCFDF2023-11-17