FDA.reportPublic FDA data

Mediflex Lapro-Flex Laproscopic Instruments

Primary DI
00842102106019
Brand
Mediflex Lapro-Flex Laproscopic Instruments
Company
FLEXBAR MACHINE CORPORATION
Model
91682
Catalog number
91682
Device description
Lapro-Flex Triangular Retractor 5mm shaft, 60mm base
Published
2017-04-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842102106019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842102106019008421021060198421021060190842102106019

GMDN Terms#

Term, Definition table
TermDefinition
Externally-anchored laparoscopic retractorA non-sterile, intraoperative surgical instrument designed for use during laparoscopic procedures to provide hands-free retraction of lower abdominal, urogenital or pelvic structures. It is inserted into the abdominal cavity through a small dedicated incision and manoeuvred into place under direct laparoscopic vision to lift the urogenital structures, and then anchored external to the body to a fixation device typically attached to the operating table. It is typically made of metal (e.g., stainless steel) and is in the form of a rod shaped to form a saddle-shaped hook, and may be available in left and right configurations. This is a reusable device intended to be sterilized prior to use.

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#

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Primary DIBrandModelCatalogPublished
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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
00842102116285Mini-Bookler Table Mounted Retractor Systems55016-IL2025-07-11
00842102116292Mini-Bookler Table Mounted Retractor Systems55017-IL2025-07-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00888937033670ONETRAC™Coopersurgical, Inc.GAD2026-07-09
00841536148473ThompsonThompson Surgical Instruments, Inc.GAD2026-07-08
00850083275341Intrace USAPILOTIS TECH LLCGAD2026-07-03
00850083275570Intrace USAPILOTIS TECH LLCGAD2026-07-03
00850083275969Intrace USAPILOTIS TECH LLCGAD2026-07-03
B8035202680ORTHOMEDORTHO-MED, INC.GAD2026-06-26
00190776421748MillenniumAvalign Technologies, Inc.GAD2026-06-24
00190776421809MillenniumAvalign Technologies, Inc.GAD2026-06-24
00190776421816MillenniumAvalign Technologies, Inc.GAD2026-06-24
00190776421830MillenniumAvalign Technologies, Inc.GAD2026-06-24
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00810220800447Adler Instrument CompanyAdler, Inc.GAD2026-06-24
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00190776421670MillenniumAvalign Technologies, Inc.GAD2026-06-23
00810158211292PRINCETONPrinceton Medical Group, Inc.GAD2026-06-23
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00840277133670Innomed, Inc.INNOMED, INC.GAD2026-06-09
04049047155324GimmiGimmi GmbHGAD2026-06-08
G453PM1580030BC0PEAK MEDICALPeak Medical Distribution Inc.GAD2026-06-08
00846159040524SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
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