FDA.reportPublic FDA data

Bookler Table Mounted Retractor Systems

Primary DI
00842102116421
Brand
Bookler Table Mounted Retractor Systems
Company
FLEXBAR MACHINE CORPORATION
Model
72072-4
Device description
"Blade, Fence, Finger, Malleable 4 x 5"" (10.2 x 12.7cm)"
Published
2026-03-19
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
00842102116421PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842102116421008421021164218421021164210842102116421

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
00842102105029Mediflex Fiber Optic Lightwand72078720782016-09-17
00842102116445Holders and Positioners - DynaTrac78002-2HP2026-04-08
00842102116438Mini-Bookler Table Mounted Retractor Systems72239-B2026-03-30
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
00842102116308Mini-Bookler Table Mounted Retractor Systems55018-IL2025-07-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD484610Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD484630Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD484640Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD484650Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD484660Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD484670Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD484680Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD484690Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD484700Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD484710Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD484720Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD9147091620Surgical DirectSurgical Direct, Inc.FFO2026-07-09
09348811114068INKAThe Trustee for KAISER FAMILY TRUSTFFO2026-05-29
09348811114075INKAThe Trustee for KAISER FAMILY TRUSTFFO2026-05-29
B382SD915097010Surgical DirectSurgical Direct, Inc.FFO2026-02-09
09348811023612INKAThe Trustee for KAISER FAMILY TRUSTFFO2025-11-19
07898506813698QuinelatoSchobell Industrial LtdaFFO2022-12-16
B382SD907632000Surgical DirectSurgical Direct, Inc.FFO2022-12-02
B382SD9228621010Surgical DirectSurgical Direct, Inc.FFO2022-12-01
00192896094710INGE LAMINA SPREADER RETRACTORSONTEC INSTRUMENTS, INC.FFO2019-03-07
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10381780269663Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269670Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269694Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03