FDA.reportPublic FDA data

Mediflex Universal Round Bar Table Mounted Retractor Systems

Primary DI
00842102114991
Brand
Mediflex Universal Round Bar Table Mounted Retractor Systems
Company
FLEXBAR MACHINE CORPORATION
Model
75590
Device description
"Universal Round bar blade, malleable, 1"" x 8"""
Published
2022-07-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FFORetractor, Self-Retaining

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFORetractor, Self-RetainingGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842102114991PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842102114991008421021149918421021149910842102114991

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retractor/retraction system blade, reusableA distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge to separate the margins of a wound/incision during a surgical procedure. It is intended to be attached to the frame (e.g., mounting ring/bar) of a surgical retraction system, or may be fixed onto a retractor handle; it does not include a handle. It is a metal device, sometimes referred to as a variable or vario retractor blade when assembled with a separate retractor handle, because it is available in a variety of lengths and sizes. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
047644935
Device count
1
Premarket exempt
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842102116469Flexarm Surgical Holders and Positioners998002026-08-03
00842102116452Deluxe Laparoscopic Instruments91491-D-CF-452026-07-28
00842102105029Mediflex Fiber Optic Lightwand72078720782016-09-17
00842102116445Holders and Positioners - DynaTrac78002-2HP2026-04-08
00842102116438Mini-Bookler Table Mounted Retractor Systems72239-B2026-03-30
00842102116421Bookler Table Mounted Retractor Systems72072-42026-03-19
00842102116391Bookler Table Mounted Retractor Systems757072026-02-09
00842102116407Bookler Table Mounted Retractor Systems69615-102026-02-09
00842102116384StrongArm Surgical Holders and Positioners212812025-11-26
00842102114618Bookler Table Mounted Retractor Systems550122021-08-18
00842102116377Bookler Table Mounted Retractor Systems750662025-09-12
00842102116360Flexarm Surgical Holders and Positioners75-99056-QC-BS012025-08-26
00842102116339Mini-Bookler Table Mounted Retractor Systems551002025-08-18
00842102116346Mini-Bookler Table Mounted Retractor Systems55100-SA2025-08-18
00842102116353Mini-Bookler Table Mounted Retractor Systems550182025-08-18
00842102116322Mediflex Universal Round Bar Table Mounted Retractor Systems75843-R2025-08-06
00842102116315Holders and Positioners - Nathanson Hooks758442025-07-28
00842102116254Mini-Bookler Table Mounted Retractor Systems55013-IL2025-07-11
00842102116261Mini-Bookler Table Mounted Retractor Systems55014-IL2025-07-11
00842102116278Mini-Bookler Table Mounted Retractor Systems55015-IL2025-07-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810238290049PRINCETONPrinceton Medical Group, Inc.FFO2026-09-22
00850088713862PRINCETONPrinceton Medical Group, Inc.FFO2026-09-22
04049047074694GimmiGimmi GmbHFFO2026-08-14
B382SD921405170Surgical DirectSurgical Direct, Inc.FFO2026-08-07
B382SD93415040Surgical DirectSurgical Direct, Inc.FFO2026-08-07
B382SD459000Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD460350Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD460360Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467000Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467010Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467020Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467030Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467040Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467050Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD48250Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD493680Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD493690Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD493770Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD6213120Surgical DirectSurgical Direct, Inc.FFO2026-08-03
00190776407483MillenniumAvalign Technologies, Inc.FFO2026-07-31
B382SD14174550Surgical DirectSurgical Direct, Inc.FFO2026-07-31
B382SD90712216T0Surgical DirectSurgical Direct, Inc.FFO2026-07-29
B382SD907581320Surgical DirectSurgical Direct, Inc.FFO2026-07-24
B382SD9075041030Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD907530128T0Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD907530129T0Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD907573330Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD9075800910Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD907580150Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD9076231100Surgical DirectSurgical Direct, Inc.FFO2026-07-17