FDA.reportPublic FDA data

Flex

Primary DI
01008501900040
Brand
Flex
Company
MEDROBOTICS CORPORATION
Model
25171
Device description
Flex Rectoscope
Published
2019-07-01
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
false

Product Codes#

Code, Name table
CodeName
FDFColonoscope And Accessories, Flexible/Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDFColonoscope And Accessories, Flexible/RigidGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
01008501900040PreviousGS10
00850190004100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
01008501900040010085019000401008501900040
00850190004100008501900041008501900041000850190004100

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
002764627
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850190004193Flex253862019-07-01
00850190004018FLEX229952019-10-30
00850190004025FLEX246982019-10-30
00850190004032FLEX246992019-10-30
00850190004070FLEX231572019-10-30
00850190004087FLEX234982019-07-01
00850190004100Flex251712019-07-01
00850190004124Flex251732019-07-01
00850190004131FLEX251782019-07-01
00850190004513FLEX253272019-04-01
00850190004520FLEX253282019-04-01
00850190004537FLEX253292018-12-07
00850190004544FLEX253302019-04-01
00850190004551FLEX253312018-12-07
00850190004568FLEX253322018-12-07
00850190004711FLEX255972019-04-30
00850190004742Flex257762019-04-01
00850190004759Flex257772019-04-01
00850190004766Flex257782019-04-01
00850190004827FLEX261142018-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809882470213ROBOPERA™ SETEndoRobotics Co., Ltd.FDF2026-10-16
08809882470220Articulated Basic Gripper GEndoRobotics Co., Ltd.FDF2026-10-16
08809882470237Articulated Dual Gripper GEndoRobotics Co., Ltd.FDF2026-10-16
08809882470381ROBOPERA™ UnitEndoRobotics Co., Ltd.FDF2026-10-16
08809882470398ROBOPERA™EndoRobotics Co., Ltd.FDF2026-10-16
08809882470404Controller AEndoRobotics Co., Ltd.FDF2026-10-16
08809882470428Controller BEndoRobotics Co., Ltd.FDF2026-10-16
08809882470442ROBOPERA™ AccessoriesEndoRobotics Co., Ltd.FDF2026-10-16
08809882470466R-Power CableEndoRobotics Co., Ltd.FDF2026-10-16
08809882470725ROBOPERA™ Storage CaseEndoRobotics Co., Ltd.FDF2026-10-16
04580826920035PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920066PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920141PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920271PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920295PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920394PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920462PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826921599PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826921742PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826921759PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826922176PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826922183PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826922190PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826925672PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826925702PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826925832PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926068PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926075PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926082PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926099PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25